![]() FDA’s Quality System Regulation Part 820 is harmonized with ISO 13485:1996, which is based on ISO 9001:1994. Food and Drug Administration regulates current good manufacturing processes (CGMP’s) also known as FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. ![]() is the relationship to FDA 21 CFR Part 820. ![]() ![]() A common question we receive in relation to regulatory requirements in the U.S. ![]() Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.
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