ANSI and its Committee on Education (CoE) work with members of the U.S. academic community to promote the incorporation of standards-related information into the curricula of U.S. colleges and universities. The following colleges and universities offer courses that teach standardization and/or utilize standards as course material.
This course covers the management of information security programs in organizations. Students are introduced to various standards that define best practices for creating and maintaining security policies and performing an enterprise risk assessment. Students are exposed to the legal, regulatory, and compliance requirements of cybersecurity. The course requires students to solve real-world security problems using a risk management approach through group project work and writing assignments.
Contact: Kenneth Knapp, [email protected]This course offers an experiential approach to applying key sustainable business principles to current business challenges and opportunities. Topics examined each week will focus on a different issue related to creating a sustainable management system. Writing, research, and presentations will assess students' readiness as sustainable business professionals and agents of change. Prerequisites: SB201 and SB315 or permission of instructor.
Contact: Bill Foley, [email protected]Methods and tools for identifying, assessing, mitigating and controlling risk in business and engineering design activities. Decision tools include cost-benefit analysis, decision trees, value of information, Bayesian statistical decision making, fault trees, and failure modes and effects analysis (FMEA).
Contact: Ali Kucukozyigit, [email protected]
Foundation course addressing the concepts needed for successful system planning, design, and build process. Topics include successfully bringing large-scale systems to completion on schedule and on budget, modeling, and cost estimating techniques, risk and variability.
Contact: Ali Kucukozyigit, [email protected]This course is part two of the culmination “Capstone” of the biomedical engineering educational experience. The primary objective of this course is to recall and enhance design principles introduced through the engineering core curriculum and to apply this systematic set of engineering design skills to biomedical engineering projects. Student teams formed in the previous semester will continue develop a design project based on an unmet clinical need with a clinical advisor, gaining hands-on process experience and generating innovative solutions.
Contact: Deborah Hurley, [email protected]
CSCI 2002, Privacy and Personal Data ProtectionIf you tried to live for one day without generating any digital personal data, how would you spend it? In the Information Age, the use of personal data has proliferated and is pervasive. This course offers a comprehensive examination of protection of privacy and personal data, which is central to autonomy, dignity, and liberty. Topics include identity, financial, health, educational, and other data. Students will learn about: Fair Information Practices; the development of modern privacy rules in the United States and around the world; Fourth Amendment privacy and the autonomy of the individual in relation to the state; key US laws (HIPAA, FERPA, GLBA, GINA, COPPA, etc.); significant international rules (European Union’s General Data Protection Regulation (GDPR), etc.); important institutions (Federal Trade Commission, Data Protection Authorities, etc.); standards; Privacy by Design and Default; and emerging issues.
Contact: Deborah Hurley, [email protected]In this course, students learn the fundamentals of materials science as applied to bioengineering design. Topics include biocompatibility, materials characterization and design, polymers, the foreign body response, blood clotting, tissue engineering, allografts and autografts, medical devices, FDA regulations, and ethical issues. Students learn how to use and apply ISO 10993 standards for biocompatibility testing, along with various other testing standards for biomaterial characterization.
Contact: Dr. Britta Berg-Johansen, [email protected]Design of a biomedically-oriented hardware or software project(s) including related instrument/device or signal or image processing concepts. Associated constraints, standards, reliability, and verification issues. Individual and group projects.
Contact: Ga-Young Kelly Suh, Ph.D., [email protected]
Implementation of a biomedically-oriented hardware or software project(s) including related instrument/device or signal or image processing concepts. Associated constraints, standards, reliability, and verification issues. Individual and group projects.
Contact: Ga-Young Kelly Suh, Ph.D., [email protected]Students learn and implement the design process to produce working prototypes of medical devices with potential commercial value to meet significant clinical needs and design standards. Critical examination of contemporary medical problems is used to develop a specific problem statement. Project planning and management, including resource allocation, milestones, use of standards and documentation, are required to ensure successful completion of projects within the allotted time and budget.
Contact: Colin Drummond, [email protected] and: Matthew Williams, [email protected]
EBME 380 - Biomedical Engineering Design ExperienceIn this second of two Senior Design Capstone courses within Biomedical Engineering, students the opportunity to integrate much of their prior coursework and laboratory activities through design projects -- many of the requirements require you to continue to refine and apply the synthesis skills you started to develop in EBME370. As a highly “experiential” course, activities are intended to closely resemble the experiences you can expect throughout the rest of your career. This course will emphasize and explore a variety of issues related to the design, development, and use of standards in medical devices and systems, demonstrating that there are not many “absolute truths,” but there are numerous best practices.
Contact: Colin Drummond, [email protected] and: Matthew Williams, [email protected]This course explores government oversight of devices and drugs, and the laws and regulations that apply to their development, testing and production. This course also examines the context in which regulations and standards have evolved, the structure of the FDA and its relationship with other regulatory agencies. Class topics will include preclinical, clinical, regulatory, and marketing factors which influence commercialization of new medical products.
Contact: Colin Drummond, [email protected]
EBME 450 - Biomedical Engineering EntrepreneurshipBiomedical engineering entrepreneurship is a unique in its interdisciplinary and multidisciplinary scope. In this course we examine medical technology innovations in the context of (A) identifying unmet clinical needs, (B) the process of conducting an opportunity analysis for an investable concept, and (C) subsequent translation of these advances into the market. This course will emphasize and explore a variety of issues related to innovation and entrepreneurship, reflecting the unique regulatory and design standard environment of medical device design. Successful students will conclude this course with new knowledge and insight on biomedical technology and innovation, as well as having demonstrated measurable improvement in their critical thinking skills.
Contact: Colin Drummond, [email protected]These courses are the capstone design courses of the School of Engineering. Students form teams to conduct research and design, and they build a prototype of a system of their own design incorporating theory-based principles and engineering standards into design projects. Projects are proposed and guided by mentors, who are engineering faculty, or scientists and engineers in local companies and government laboratories. Teams create one formal document, a full final report, and a prototype. There are also midterm and final presentations, and the prototypes are evaluated. Teams consist of various engineering disciplines and have specific multi-disciplinary applications and approaches.
Contact: Dr. Vignola and Dr. RaubThis course will teach the knowledge that archivists need to know in order to evaluate current recordkeeping practices as the basis for managing the records of contemporary organizations. It will provide an understanding of the traditional theory, methods, and practices of records management. This course incorporates the principles and theory necessary for the management and preservation of digital records using national and international standards.
Contact: Penny Cliff, [email protected]The following three courses in the Master’s of Science in Aviation and Aerospace Sustainability and Gradual Certificate in Aviation and Aerospace Sustainability program include discussion of ISO international standards:
SYS 301 Introduction to Systems EngineeringProvides an overview of systems engineering in the development of large systems, including genesis and need, characteristics of systems and system engineers, the system life cycle (from birth to death), design for operational feasibility, project management, structure, and system control, statistical/probabilistic models in dealing with risk inherent in large, complex systems. Emphasis on the importance of system requirements regarding total system performance, interfaces, cost, schedule, optimization, and trades. We also cover various applicable standards used by Systems Engineers.
Contact: Chetan Date, [email protected]
SYS 301 Introduction to Systems EngineeringBuilds on basic concepts introduced in SYS 301 dealing with system testing and the specialty engineering disciplines of reliability, maintainability, supportability, producibility. Probability and statistics are reviewed and applied in these areas. Students gain a comprehensive understanding of the elements of specialty engineering, as well as the skills to apply those elements. We also cover ISO/AS9100 compliance system to manage FAA regulatory products and associated risks.
Contact: Chetan Date, [email protected]
AASI 600 Sustainable Aviation and Aerospace Perspectives
An examination of aviation/aerospace's interaction with the world from the viewpoint of positive and negative effects. Short-term and long-term effects will be investigated to highlight the significant challenges associated with forming a sustainable future for the industry by examining case studies and best management and technology practices.
Investigate sustainable operations of aviation and aerospace organizations. Analyze how the distinctive operations of aviation and aerospace organizations could move along with sustainability practices. Sustainable strategies must be a core element within aviation and aerospace organizations; the development of a sustainable strategy should consider the distinctive characteristics of the industry and the interactions among its stakeholders.
Contact: Eva Maleviti, [email protected]
AASI 635 Sustainable Aviation Techniques and toolsTechniques and tools for sustainability in aviation and aerospace operations. Lean management, Six Sigma and ISO standards, sustainability guiding principles, risk management standards, and result-oriented quality tools are necessary for all auditing processes of a sustainable system.
Contact: Eva Maleviti, [email protected]
ASCI 693 - Current Research Problems in Aviation and Aerospace
Equips students with applied research techniques and skills. Current aviation/aerospace problems are resolved using accessible qualitative and quantitative data for rapid analysis, creating recommendations suitable for industry practitioners. Problems encountered as an aviation/aerospace professional working in the industry are solved. Synthesizes current, relevant literature, challenging students to critically analyze and interpret research findings of others as a foundation for creative problem solving. Presents forum for debate on current aviation/aerospace issues resulting in potential strategic solutions. Requires students to present applied research designs, rationale, and solutions for evaluation. Prerequisite(s): None
Contact: Leila A Halawi, [email protected]
CIV 222 - Introduction to Environmental Engineering
This course covers the fundamentals of environmental engineering. It begins by describing the fundamental principles that serve as the foundation of the entire field of environmental engineering. Applications in water quality, air quality, and hazardous waste management will be covered using quantitative problems which enable students to apply what they have learned and develop problem-solving skills.
The course focuses on two important issues for businesses and other organizations – ethical behavior and social responsibility - and especially upon those situations that require moral reflection, judgment, and decision. The course examines contemporary concepts of business ethics and social responsibility and explores current problems that require moral and ethical reasoning.
Contact: Anita Fagerman, [email protected]First course in a two-semester capstone design sequence for bioengineers. Includes capstone project problem definition, competitive benchmarking, design metrics and specifications, realistic constraints including ethical, regulatory, intellectual property, and standards. Also generation of potential project solution strategies and concept selection.
Contact: Derek J. Lura, [email protected]In a highly connected, data intensive, and cost-focused business environment, the practice of information security not a business advantage; it is a customer requirement. Viruses, malware, trojans, denial of service attacks, phishing, and even Wiki leaks have become headline news. Failure to insure the confidentiality, integrity, and availability of data costs companies millions, if not billions of dollars in legal settlements, lost business, and trade secrets. In this breadth-based course, you will get an overview of information security principles and practices, including security models, risk management, access controls, intrusion detection and prevention, cryptography, software vulnerabilities, and ethical issues. Subsequent courses expand on this foundational material in much greater depth.
Contact: Bilge Karabacak, [email protected]
ISEC 350 Risk ManagementProper assessment, management, and mitigation of risk are essential to any information security strategy. Risks aren't just related to IT assets, but to the overall business that the IT organization is supporting, thus, business continuity planning and impact analysis is also important. In this course, you will learn how to identify and analyze risks, determine impacts, and develop plans to mitigate issues. Topics include threats, vulnerabilities, exploits, and countermeasures; US compliance laws; risk assessment and mitigation; business impact analysis; and business continuity and disaster recovery planning.
Contact: Bilge Karabacak, [email protected]
ISEC 475 Security Engineering and AssessmentEnsuring the confidentiality, integrity, and availability of large and complex systems is notoriously difficult in the face of capable and determined opponents. This course discusses security engineering as the practical application of requirements analysis, modeling, architecture, processes, and measurement toward improving the dependability of complex information systems throughout their lifecycle.
Contact: Bilge Karabacak, [email protected]
ISEC 610 Information AssuranceThis course covers the fundamentals of security in the enterprise environment. Included are coverage of risks and vulnerabilities, threat modeling, policy formation, controls and protection methods, encryption and authentication technologies, network security, cryptography, personnel and physical security issues, as well as ethical and legal issues. This foundational course serves as an introduction to many of the subsequent topics discussed in depth in later security courses.
Contact: Bilge Karabacak, [email protected]
ISEC 630 Information Risk ManagementWhen audits, technology, or compliance become the driver for security initiatives the resulting program is strategically fragmented, reactive, and rigid. Moreover, there are few, if any, assurances that the biggest threats are being addressed. On the other hand, risk assessment places values on assets, evaluates the current controls, and provides data to improve the protection in a controlled, proactive, and flexible manner. This course teaches an approach to security that combines operational security, risk assessment, test and review and mitigation such that value can be demonstrated. A project-based approach to risk assessment is followed including, project definition and preparation, data gathering, technical information, physical data gathering, analysis, mitigation, recommendations, and reporting.
Contact: Bilge Karabacak, [email protected]
ISEC 660 Information Security Policy & GovernanceThe prevalence of data breaches, identity theft, and the dark net today makes the study of digital cybercrime, ethics, and compliance highly relevant to information security. Laws related to intellectual property, privacy, and criminal and civil proceedings will be discussed. Ethical behavior and frameworks for navigating between customer and business concerns in the workplace are also emphasized.
Contact: Bilge Karabacak, [email protected]
Learning and knowledge management is crucial to the success of organizations. In this course, students will go beyond the design of learning environments and acquire skills to lead and manage the learning organization at a strategic level. Students will be able to recognize and meet the evolving learning needs of an organization within the framework of the organization's strategic goals. Multicultural awareness and how to lead multi-functional and cross-cultural instructional design teams and projects will also be addressed in this course.
Contact: Meir Russ, [email protected]Managing Occupational Health and Safety (OH&S) for the purpose of improved organizational performance requires a systematic set of processes, employee engagement, and internal checks and balances uniquely tailored to the needs and conditions of an organization. ISO 45001:2018, an international standard, and ANSI/ASSP Z10.0-2019, an American national standard, define processes needed for continual improvement in OH&S performance. This course will cover the requirements of ISO 4500 and ANSI Z10.0 as frameworks for OH&S efforts and other management systems that may be in place within an organization. Additionally, this course will use ISO 45001 and ANSI Z10.0 as lenses for discussion and reflection on topics such as Serious Injury and Fatality (SIF) Prevention, Psychological Safety, and Human and Organizational Performance. The knowledge gained from this course will prepare general industry, services, and construction participants to facilitate their organizations in attaining higher-level OH&S performance and provide an assessment of readiness for ISO 45001 and ANSI Z10.0 implementation.
Contact: Christopher Clanton, [email protected]This undergraduate-level course focuses on theoretical and practical aspects of design of machine elements for stress. Students of this courses will apply concepts of mechanics of materials to the analysis and design of machine components. They will study the stress-strain and force-deflection relations in machine components as well as the fundamental approaches to stress and fatigue analysis and failure prevention. They will learn and apply design methods for machine components such as shafts, bearings, springs, bolted and welded joints, among others
Contact: Andres Tovar, [email protected]Biomedical engineers are uniquely involved in many aspects of product development, from the inception of the idea to its delivery in the marketplace. This course will cover one major aspect of that process—the objectives and mechanisms of the FDA regulatory system governing the clinical use of medical devices in the United States, including regulatory pathways and device classification. Students will both analyze and discuss management of risk, and they will design controls related to cardiovascular, orthopedic, and neurological devices. By the end of the course, students will have a deep understanding of how the regulatory process is involved in every phase of medical device development.
Contact: Arielle Drummond, [email protected]
AS.410.717. Risk Assessment and Management. 4 Credits
Risk analysis is composed of three separate but integrated elements, namely, risk assessment, risk management, and risk communication. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk management is the process of weighing policy alternatives in light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. Students will learn how to integrate risk assessment, risk management, and risk communication using case studies.
This is the first course in a three-quarter capstone design sequence for nanosystems engineering. Open-ended, team-based engineering design project that draws on the student’s entire academic experience with emphasis on idea generation and conceptual design. The project utilizes the engineering design process. The second course is a continuation with emphasis on detailed system design. The third course is on prototype construction and evaluation. The students address a broad range of design requirements including performance, economic, environmental, manufacturing, ethical, safety, and social.
Contact: Sandra Zivanovic, [email protected]The localization industry is experiencing explosive growth in language-access needs, alongside the rapidly evolving technology that is impacting traditional localization roles. This landscape could be very advantageous for our industry if lack of standardization and the race to the bottom at per word prices and sentence-by-sentence translations were not the norm. The subject of this course is the state of the localization industry in five key areas: de facto (or market-established) standards, education, regulations, technology, and localization industry standards. Students will first learn about how the United States performs in each of these areas, before presenting how a country or market of their choosing performs. The final project will be to identify an aspect of the localization industry in the country or market under research that requires standardization and to present on how that standardization could be achieved.
Contact: Alaina Brandt, [email protected]This course is an introduction to life-cycle thinking and the circular economy with emphasis on quantitative sustainability assessment and decision-making.
Contact: Daniel Gingerich, [email protected]This course is taught to first year residents in the Orthodontics program (and Pediatrics in the past). It emphasizes basic material science theories as they relate to the use of metals, ceramics, and polymers in orthodontic and pediatric dentistry. The primary purpose of this course is to provide the student with knowledge of 1) the general nature and composition of dental materials, 2) the physical properties of materials used in dentistry and medicine, and 3) the indications for and proper use of dental materials. Fluoride, allergies and biocompatibility are also discussed.
Contact: Jack L. Ferracane, [email protected]This course explores the design, evaluation, and documentation of engineering specifications required for manufacturability and assembly are introduced. Emphasis is on CAD-based detail assemblies, design layouts, equipment installations, and related industrial practices.
Contact: Paul McPherson, [email protected]Introduction to software-engineering principles with special emphasis on the process, methods, and tools needed to develop and test quality software products and systems, and team management.
Contact: James Davis, [email protected]
ECE 595: Advanced Software EngineeringSoftware engineering is a complex endeavor. Software engineers work in diverse teams to create and comprehend complex information, such as: code structure, implementation rationale, dynamic software behavior, change implications, and team dynamics. In this class, we will learn modern software engineering practices and discuss state-of-the-art research in software engineering. The students will work on research projects to understand and extend the state of the art in software engineering.
Contact: James Davis, [email protected]This laboratory course provides students with skills used in hydrologic investigations, investigations of contaminated sites, and environmental assessments. Students will learn field skills to support surface water investigations, groundwater investigations, and investigations of contaminated sites. Students will also learn to specify sampling and chemical analysis for contaminated sites, and to use common water quality field analytical instruments. In this lab we will learn the fundamentals of hydrology field, office, and computer techniques. The course includes laboratory experiments, field hydrologic measurements, computer software applications, and data analysis exercises, and uses ASTM E1527-21 Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process.
Contact: Josh Goldowitz, [email protected]
ESHS 350 Greenhouse Gas ManagementThis course introduces the scientific basis of the greenhouse effect, the global carbon cycle and climate change, and identifies and explores methods used to determine an organization’s GHG output. Mechanisms used by industry, governmental organizations and commercial enterprises to remain competitive as the world transitions to a low carbon economy will be explored. Students will gain GHG inventorying skills presented in ISO 14064 and the WRI Greenhouse Gas Protocol, and will gain fundamental understanding of the causes, effects, and possible mitigation strategies for climate change.
Contact: Josh Goldowitz, [email protected]In this course, historical and modern accident and incident causation models and theories will be covered. Students will learn how to identify and prevent unsafe acts and conditions that can lead to accidents and incidents. The application of management system controls, including operational controls to prevent accidents and incidents will be reviewed. In addition, students will learn how to investigate accidents and incidents and how develop accident and incident investigation written programs.
Contact: Joe Rosenbeck, [email protected]
ESHS 515 Corporate EHS Management- Uses ISO 14001, ISO 45001, ANSI Z10This course presents the fundamentals of how companies manage their environmental, health and safety (EHS) issues. EHS motivations and strategies for corporate environmental management will be explored. Organizational considerations for managing corporate EHS programs will be identified. Total quality management and its applications to corporate EHS problem solving will be introduced. The basic elements of EHS management systems will be reviewed. EHS training and corporate EHS reporting will also be examined.
Contact: Joe Rosenbeck, [email protected]Discussion of machine safety with emphasis on hazard analysis, risk estimation, safeguarding techniques, and electrical safety. Particular attention will be paid to applicable OSHA, ANSI, NFPA, and ISO standards as they relate to wood, metal, films, and automation.
Contact: Josh Goldowitz, [email protected]This is the initial course in RIT's online MS degree program in Environmental, Health and Safety (EHS) Management. The curriculum focuses on EHS and sustainability management within an organization, and introduces students to EHS management systems and the ISO 14001 and 45001 standards.
Contact: Joe Rosenbeck, [email protected]; Lisa Greenwood, [email protected]
ESHS 740 EHS Management System DesignThis course integrates the use of ISO 14001 and 45001 management system standards and examines the design and development of environmental, health and safety management systems in order to implement an organization's policies. It offers strategies for measurement of results in order to assess performance and ensure continual improvement.
Contact: Joe Rosenbeck, [email protected]; Lisa Greenwood, [email protected]
ESHS 755 Corporate Social ResponsibilityThis course introduces social responsibility concepts and approaches presented in key documents like the ISO 26000 Social Responsibility Standard and the AA1000 standard on stakeholder engagement, and explores strategies for assisting an organization to identify and implement socially responsible initiatives appropriate to the nature and scope of its activities, products, and services.
Contact: Joe Rosenbeck, [email protected]; Lisa Greenwood, [email protected]This course examines strategies for integrating EHS systems and processes. Using case studies, the course explores interrelationships between EHS and: total quality management, business value, reporting, and approaches for sustainable business development. Students will be prepared to select appropriate quality tools to improve EHS processes; identify opportunities, strategies and tools for integrating EHS into business management; and identify best practices in EHS/business integration.
Contact: Joe Rosenbeck, [email protected]This course provides an overview of the fundamentals of EHS internal auditing, including EHS internal audit program design and management principles, management system performance evaluation and corrective action techniques, and system improvements.
Contact: Joe Rosenbeck, [email protected]; Lisa Greenwood, [email protected]3D audio refers to a method to generate and deliver an immersive audio field that is integrated with 3D video. The course covers theoretical and practical aspects of 3D audio: capturing auditory information of a venue using multi-microphone techniques (discrete multichannel methods, microphone arrays, and binaural capture), rendering the captured information using spatial signal processing (Inverse filtering, VBAP and Crosstalk Cancellation), transmitting and delivering as multichannel audio format, and recreating the original auditory information (multichannel loudspeaker reproduction and applying inverse filter for room compensation). In addition, the course will teach the fundamentals of the architectural acoustics (acoustics of a space) and the psycho-acoustics (recognized acoustics by listeners). The course includes practical exercises through which students can evaluate the spatial audio techniques discussed in the course and reproduce immersive multichannel sound and music.
Contact: Dr. Sungyoung Kim, [email protected]In this course, standard laboratory tests are performed for evaluating the properties of soils including gradation, plasticity, compaction, permeability, compressibility, and shear strength, using ASTM standards.
Contact: Teresa Wolcott, [email protected]Fundamentals of manufacturing processes such as machining, forming, casting, molding and welding. Surface treatments, powder-based processes, and microfabrication methods. Materials behavior and selection for manufacturing. Geometric dimensions and tolerancing.
Contact: Sang-Joon (John) Lee, [email protected]Developing a new therapy for a medical condition is an exciting but complex process. Patients and physicians rely on innovative companies and individuals to discover, design, evaluate, and release therapies that heal injuries, save lives, and relieve discomfort. Clinical Research, Regulatory, and Quality professionals play an essential role in the development process, and understanding the process is foundational for someone working in their respective fields. This course will cover all the phases of developing a medical device. The content will include an overview of the activities in each stage and the role that the professionals in the medical device functional groups play.
Contact: Will Collis-Prather, [email protected]
ACR 628 – Regulatory Compliance & Research EthicsThis course covers the principles, regulations, and ethical considerations of conducting clinical research on investigational or marketed medical devices. We will discuss pre and post market approval requirements under the FDA Investigational Device Exemption (IDE) regulations and the logistics of conducting clinical trials. We present principles of clinical trial design, including clinical objectives, epidemiological, and statistical considerations. We will discuss standard study designs and their scientific and practical advantages and disadvantages. We will also present the Clinical Product and Trial Life Cycle (Planning, Initiation, Execution, and Closure).
Contact: Will Collis-Prather, [email protected]
ACR 634 – Clinical Risk Management & SafetyIn medical device product development and clinical research, there is the potential for risk to the patients (safety), the physicians (liability), and the sponsor (regulatory, financial, legal). As a clinical research professional, you may be responsible for monitoring and mitigating risk during clinical trials. You may also be involved in cross-functional risk assessments during the product development process. This course will cover the regulations and expectations related to clinical research risk analysis, mitigation, assurance, and control.
Contact: Will Collis-Prather, [email protected]
ACR 636 – Communications & Reporting for Clinical TrialsThis course provides a detailed understanding of the topics and techniques used to plan a regulated human clinical trial. Specific topics include investigational plan (protocol) development, study design options, study endpoint selection, choice of control groups, patient population determination, and site selection. In addition, we will cover various aspects of clinical research planning, including creating a project plan, budgeting, data management, statistical analysis, safety data collection and reporting, monitoring, outsourcing, and investigational device forecasting.
Contact: Will Collis-Prather, [email protected]This course is designed to provide the student a general understanding and overview of:
Contact: Cathy Krier, [email protected]
MTQ 624 - Risk ManagementThis course provides an overview of the risk management process as it applies to the development and use of medical devices so as to protect patients, operators, and medical professionals from harm. Applicable standards and regulations will be covered, as well as methods and tools for identifying, analyzing, and controlling risks and hazards.
Contact: Cathy Krier, [email protected]
MTQ 626 - Medical Technology Quality SystemsThis course is designed to provide the student a general understanding and overview of:
Contact: Cathy Krier, [email protected]
MTQ628 - Design Control and Product DevelopmentThis course is designed to provide the student a detailed understanding and overview of FDA and ISO design control requirements for MedTech product development, translation of user needs into product design, risk management in the design process, and how design reviews and using a phased approach help assure designs are safe, robust, and effective.
Contact: Cathy Krier, [email protected]
RAS 635 – Regulatory Affairs ComplianceThis class instructs about medical device post market regulations associated with device product listing, facility registration, product complaint management, aware of other considerations associated with compliance such as liability, root cause analyses, effective communication, and ethical considerations.
Contact: Cathy Krier, [email protected]
RAS 627This class teaches the area of International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada Regulatory requirements.
Contact: Cathy Krier, [email protected]
RAS 695 – Special Topics in Reg. Affairs: Medical Device Global Quality ScienceThis is a new class that provides an introduction to the medical device industry and the role of the Regulatory Affairs and Quality Assurance professionals.
Contact: Cathy Krier, [email protected]This course introduces the basic principles and concepts of Enterprise Risk Management (ERM). You gain an understanding of how ERM integrates into an organization's governance structure and processes and explore the drivers for and value of an ERM program. Topics include risk oversight and leadership, ERM and strategic management, and the evolving landscape of ERM. Learn how ERM aligns with internal control, audit, and compliance functions. Course materials and discussions include an examination of how an enterprise risk management framework and processes are applied in different organizations, and concludes with examples and discussions of organizations that have mature enterprise risk management programs.
Contact: Carrie Frandsen, [email protected]
MGMT X 408.810 Designing and Implementing an Enterprise Risk Management ProgramThis course introduces the concepts and skills to effectively design and implement an enterprise risk management program that is tailored to an organization's culture, governance structure, and current management processes. Through class discussion and case studies, students explore common barriers to effective ERM implementation and learn techniques to overcome them. Internal and external influences on an organization's risk management approach are also examined. Students are introduced to enterprise risk assessment methods and facilitation techniques. The course includes student work with selected case exercises that reinforce key learning objectives.
Contact: Carrie Frandsen, [email protected]
MGMT X 408.813 Enterprise Risk Management: Advanced TechniquesThis course builds on the previous ERM certificate courses to further student’s knowledge of topics in business strategy (including principles of competitive strategy and competitive analysis, resource and value chain analysis); strategic risk management (including tools to link strategy and risk, integrating risk management into the organization’s strategy architecture, scenario planning, war gaming and risk ownership maps); risk assessment techniques (including the selection and use of various techniques during the risk management process, probability, and other quantitative risk assessment techniques); risk transfer (including insurance, reinsurance, loss control, alternative risk transfer techniques such as catastrophe insurance and captives, and actuarial science); an introduction to market, credit, and supply chain risk management; applied decision science; executive and board reporting; and the risk management job market. Students learn through readings, class discussion, case studies, and a class project that reinforces key learning objectives.
Typically Offered: Spring
The Quality Management Systems course provides an in depth look into the FDA Quality System Regulation (21CFR820), and International Standard ISO 13485 for Quality Management Systems, and introduces related aspects of Risk Management (ISO 14971).
Contact: Robert Duffy, [email protected]
BIOL-40324 Design Control for Medical DevicesThe Design Control course provides a detailed and practical overview of the design control process for medical device design and development. The course covers design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and labels. The course also introduces related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).
Contact: Robert Duffy, [email protected]Consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. Lessons address the integration of human factors and usability into the product development lifecycle, regulatory considerations, standards, and human factors methods.
Contact: Niranjan Maharajh, [email protected]
MEDD.X409 Risk Management for Regulated IndustriesThis course discusses how risk management is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and workshops delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System. By the end of the course, you'll be able to conduct risk management for a variety of products, processes and services within the biomedical industries and beyond.
Contact: Niranjan Maharajh, [email protected]
MEDD.X410 Validating Software for Medical Devices and Emerging TechnologiesWith the increasing number of medical devices running on software, there is an enormous demand for quality assurance and regulatory affairs professionals who can address the validation, documentation, compliance and submission requirements unique to software-controlled devices. This how-to course covers the requirements for validation for all types of software, including Class II and III embedded medical device software, digital health apps, software as a medical device, medical device data systems, manufacturing software, automated test software, process software, quality system software, and spreadsheets. Student engage in interactive classroom discussions and an in-depth survey of the regulations, guidance documents and standards specific to medical device software and validation.
Contact: Niranjan Maharajh, [email protected]Utilizes the ISO 230 "Test code for machine tools" series of standards. The course not only covers information in the standards but also has an associated weekly practicum which allows students to learn in a hands-on environment the techniques that are communicated through the standards.
Contact: Jimmie Miller, [email protected]
MEGR 7282, 2182 - Computer-Aided Process Planning
Theory and computing methods for the specification, manufacture, and verification of manufactured artifacts with a particular emphasis on precision engineering applications. Representation of engineering designs. Feature recognition. Generation of manufacturing and metrology instructions. Computer software implementation projects.
Contact: Brigid Mullany, [email protected]
MEGR 7283 - Advanced Coordinate Metrology
Error compensation of coordinate measuring machines, algorithms and sampling methods used in data analysis. Probing systems, compensation of probing errors. Scanning coordinate measuring machines and their dynamic behavior. Performance testing of coordinate measuring machines.
Contact: Dr. Ed Morse, [email protected]
MEGR 8283 - Advanced Coordinate Metrology
Error compensation of coordinate measuring machines, algorithms and sampling methods used in data analysis. Probing systems, compensation of probing errors. Scanning coordinate measuring machines and their dynamic behavior. Performance testing of coordinate measuring machines.
Contact: Dr. Ed Morse, [email protected]
MEGR 7186 - Data Analysis and UncertaintyIntended for graduate students from science and engineering disciplines, with a focus on optical engineering and mechanical engineering. Introduces the principles of measurement uncertainty assessment, uncertainty analysis methodologies, and data analysis/reduction techniques. Topics include: terminology and basic theory of measurement uncertainty, techniques for assessing uncertainty sources, and basic data analysis and data reduction strategies to include fit parameter uncertainty assessment.
Contact: Dr. Ed Morse, [email protected]
MEGR 8186 - Data Analysis and UncertaintyIntended for graduate students from science and engineering disciplines, with a focus on optical engineering and mechanical engineering. Introduces the principles of measurement uncertainty assessment, uncertainty analysis methodologies, and data analysis/reduction techniques. Topics include: terminology and basic theory of measurement uncertainty, techniques for assessing uncertainty sources, and basic data analysis and data reduction strategies to include fit parameter uncertainty assessment.
Contact: Dr. Ed Morse, [email protected]
MEGR 3282 - Statistical Process Control and MetrologyTechnical Elective. Introduction to metrology. Measurement of size, form and surface texture. Introduction to quality control, control charts for attributes and variables, acceptance sampling. Process capability estimation and process control.
Contact: Dr. Ed Morse, [email protected]
MEGR 6181 - Engineering MetrologyIntroduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]
MEGR 6381 - Engineering MetrologyIntroduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]
MEGR 8181 - Engineering MetrologyIntroduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]
MEGR 8381 - Engineering Metrology
Introduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]
OPTI 6381 - Engineering MetrologyIntroduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]
OPTI 8381 - Engineering MetrologyIntroduction to metrology and standards. Uncertainty, precision and accuracy in metrology. Measurement of size and form, computational methods in measurement of form. Measurement of surface texture and out of roundness. Machine tool and robot accuracy and calibration. Evaluation of screw threads and gears. Introduction to design of precision instruments.
Contact: Dr. Ed Morse, [email protected]Students will explore the term safety as well as each of the three main areas of instruction in the program. Students will be introduced to System Safety and Prevention through Design by looking at the process for hazard identification and risk assessment completing a PHL to demonstrate mastery. Students will receive a primer on safety management systems completing a project exploring how their company conforms to the expectations of a management system standard. Finally, students will explore human factors through discussions surrounding leadership and culture culminating in a final group project.
Contact: Donald Burke, [email protected] 205-975-3891Process and methodologies associated with human-environmental and ecological risk assessments. Environmental risk assessments based on human receptors as endpoints, addressing predominantly abiotic processes. Ecological risk assessments based on non-human receptors as endpoints. Approach using hazard definition, effects assessment, risk estimation, and risk management. Application of methods to student projects to gain experience in defining and quantifying uncertainty associated with human perturbation, management, and restoration of environmental and ecological processes.
Contact: Marty D. Matlock, [email protected]
BENG 5623: Life Cycle Assessment, using ISO 14001-14040 series. This course is taught through Blackboard.This course is a project-based introduction to the theory and application of the life cycle assessment methodology. Students will conduct parallel life cycle assessments using the commercial software SimaPro™ and the open-source software OpenLCA. The goal of this course is to develop a fundamental understanding of LCA: What it is, what it is used for, and how to do it. This course will guide students through each step in conducting an LCA through hands on modeling. Participants in this course will learn how to properly define the goal and scope, build a life cycle inventory from government databases, use process models to produce inventory data, conduct life cycle impact assessments, and interpret results.
Contact: Marty D. Matlock, [email protected]Design strategies, techniques, tools, and protocols commonly encountered in biomedical engineering; industrial design experience in group projects; ethics, economic analysis, and FDA product approval. Materials fee.
Contact: Christine King, PhD, [email protected]This course explores systems of trust and the technologies used to support them. Students will take an interdisciplinary look at the assessment of risk and explore modern methods used to cover various types of risks.
Contact: Stephen Fitzgerald, [email protected]Biomedical engineering problems from industrial and clinical applications are addressed and solved in small groups using problem-based learning methodologies. Team-oriented design project in biomedical engineering, incorporating engineering standards and realistic design constraints. Includes introduction to relevant regulatory, intellectual property, and business management topics.
Contact: Sarah Rooney, [email protected]
BMEG260: Introduction to Medical Device DesignIntroduction to the design, development, and translation of medical devices from bench-to-bedside. Topics include translating the voice of the customer into engineering design requirements, computer-aided design, regulatory pathways, ethics, and teamwork.
Contact: Sarah Rooney, [email protected]Safety history and litigation; accident causation; safety organizations and agencies. Approaches to occupational safety and risk management. Product defects and safety program development; product liability; consumer product safety commission. Hazard communication standard. Workers’ compensation. OSHA safety standards and codes; OSHA record keeping. Common occupational hazards.
Contact: Boyi Hu, [email protected]Introduction to the economic and regulatory aspects of biomedical engineering product design. Covers elements of needs research and marketing. The protection of intellectual property is also addressed, along with medical device testing, regulation, and finance.
Contact: Caitlin Howell, [email protected]Experimental evaluation of ignition, flame spread, rate of heat release and smoke production of flammable gases, liquids, solids, and interior finish materials. Analytical and computer methods for the design, performance, and analysis of fire experiments. Preparation of laboratory reports.
Contact: Peter Sunderland, [email protected]Introduction to fire protection engineering and building regulation focusing on building safety systems, egress system design and evacuation modeling.
Contact: Peter Sunderland, [email protected]Introduction to aqueous fire suppression. Discussion of key fluid dynamics and heat transfer processes in aqueous fire suppression. System design and performance analysis based on national standards, hydraulic theory and elementary fluid dynamics and heat transfer.
Contact: Peter Sunderland, [email protected]Analysis of application and theory of fire suppression systems. The key elements of fire suppression systems will be discussed along with how they interact for effective fire suppression design. Physical mechanisms for a variety of fire suppression approaches will be discussed including hose streams, sprinklers, water mist, foam, clean agents, and chemical agents.
Contact: Peter Sunderland, [email protected]Appraisal and measurement of fire safety. Application of systems analysis, probability theory, engineering economy and risk management in the identification and synthesis of components of fire protection engineering. Methods for the development of criteria for the design, evaluation and assessment of fire safety or component hazards.
Contact: Peter Sunderland, [email protected]Fractional effective dose (FED) methods for predicting time to incapacitation and death of fires for use in fire safety calculations. Physiology and toxicology of the fire effluent components, decomposition chemistry of common materials, standard experimental approaches. Predictive models of material production rates. People movement characteristics related to building evacuation. Formulation and application of evacuation models. Human behavior factors affecting response of people to fire situations.
Contact: Peter Sunderland, [email protected]Analysis of hazard posed by smoke in buildings. Performance characteristics of smoke management systems. Review of analytical design aids. Functional analysis and design of fire detection and alerting systems. Examination and evaluation of code criteria, performance specifications and research.
Contact: Peter Sunderland, [email protected]Student teams work on design projects that demonstrate an ability to design (or redesign) a mechanical system to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability. The projects must demonstrate an understanding of the project’s potential impact in a global, economic, environmental, and societal context. The projects must involve significant use of engineering tools and standards, the results of which are used to inform design decisions. Models are used to predict the behavior and optimize the design.
Contact: Jim Lagrant, [email protected]The goal of any manufacturing enterprise should be to obtain safe, dependable, satisfactory, and economical production within the operating constraints of the process. Students will gain foundational knowledge of industrial control systems focused on manufacturing automation. The course will concentrate on the selection and application of commercial sensors, actuators, and controllers to meet the needs of an individual process, or an enterprise-wide operation. Students will gain an understanding of automation system design to support data collection, and storage to support the objectives of an Industry 4.0 connected enterprise.
Graduate level students will individually complete an additional project whereby they create a human machine interface (HMI) for the MIE Smart Manufacturing Pilot process. Students will design their HMI to be compliant with ANSI/ISA-101.01-2015, Human Machine Interfaces for Process Automation Systems.
Contact: Jim LagrantCourse provides students with understanding of the global regulatory environment in which the medical device industry operates. Students gain a fundamental understanding of critical quality systems regulations including ISO13485/ISO14971 and their relationship to the FDA's cGMP regulations. Students gain practical experience using tools that are essential to both product development and continuation/sustaining engineering including, design control procedures, FMEA, verification and validation, internal and external (supplier) management, and audit methods. Prereq: MDI graduate student only.
Contact: Mac Mckee, [email protected]Introduction to risk assessment models, methodologies, and processes. Examination of how cybersecurity risks are part of an organizations’ overall risk. Study of the techniques and guidelines used to perform a cybersecurity risk assessment of a system, process, or organization and appropriate mitigations.
Contact: Bilge Karabacak, [email protected]Students will work in small teams to build battery devices, electrolyzers for the production of chemicals and/or fuels, fuel cells, and perform industrially relevant corrosion and electrodeposition studies. They will test the performance and response of these devices compared to theory and modelling, applying experimental design and statistical analysis methods. Link: https://electrochemistry.uoregon.edu/masters-internship-program
Contact: Gary Harlow, [email protected]This course is designed to give engineers practical information about how optical components (lenses) are made and tested, and provide basic tools to create cost-effective optical system designs. Topics covered include optical material properties, grinding, polishing, CNC programming for optical fabrication, modern fabrication technologies, surface testing and fabrication tolerances. We will discuss case studies of challenging fabrication projects for leading-edge optical systems. The accompanying lab will use the facilities of the Hopkins Center fabrication and metrology labs to introduce polishing and metrology techniques. Lab exercises will include hands-on experiments, such as exploring the properties of optical materials, measuring the removal function of a sub-aperture polishing and grinding machines, and characterizing the surface form and texture of polished surfaces.
Contact: Jessica DeGroote Nelson, [email protected]
OPT 433 – Optical Fabrication and Testing Technology
You will be given a first-hand working knowledge of optical glasses, their properties, and the methods for specifying, manufacturing and testing high quality optical components. Lectures emphasize the optical and physical properties of glass, and how these influence the grinding and polishing process. Conventional fixed/loose abrasive grinding and pitch polishing are examined. New concepts for optical manufacturing are covered. The meaning of specifications will be reviewed. The laboratory portion of the course exposes you to abrasive grits, slurries, pitch polishing and the vagarious nature of the conventional polishing process. Glass types and part shapes are assigned to illustrate the degree of difficulty required to achieve optical quality surfaces with hand and machine operations. In-process metrology is performed with a variety of instruments.
This course introduces the principles and practices involved in managing data, information, and records in private, not-for-profit, and public-sector organizations.
Contact: Ciaran B. Trace, [email protected]This seminar will cover the intersection of intellectual property (patents, copyrights and trademarks) with principles of antitrust law and market competition, both domestically and internationally. Topics will include anticompetitive licensing practices, IP misuse, pharmaceutical settlements, collaboration among competitors, industry standards and IP pooling. There will be weekly reading assignments, class discussion and presentations, and a final paper that satisfies the seminar writing requirement. A basic knowledge of IP law is required. No previous antitrust or international law experience is necessary.
Contact: Jorge Contreras, [email protected]4015: Apply biomedical engineering principles to the design of an approved project using the team approach. Develop design and communication skills. Integrate ethical, global and social issues in engineering. 4016: Apply biomedical engineering principles to develop solutions for an approved design project using a team approach. Complete a project resulting in prototype medical device, circuit, or system. Refine design and communication. Integrate ethical, global, environmental and social issues in engineering. Pre: Senior standing for 4015. Pre: 3034, 3184 for 4015; 4015 for 4016. (2H,3L,3C)
Contact: Chris Arena, [email protected]Part of Virginia Tech's Industrial & Systems Engineering (ISE) senior design course. Survey of methods, tools and techniques used to plan, communicate, manage and control projects. Students work in teams to develop a proposal for and implement an industrial engineering design project for actual manufacturing or service industry clients. Addresses referencing and using standards.
Contact: Natalie Cherbaka, [email protected]
