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ANSI articles tagged with medical device are displayed below.

FDA to Harmonize Quality System Requirements for Medical Devices through Adoption of ISO Management Standard
In an effort to harmonize and modernize the quality system regulation of medical devices, the U.S. Food and Drug Administration (FDA) has announced its intention to adopt the specifications of ISO 13485, an international consensus standard for medical device manufacture developed by the International Organization for Standardization (ISO) under U.S. leadership.
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Voluntary Standards Cover the Spectrum: from Environmental and Facility Safety Signs to Medical Device Sterilization
In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI)
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