Regulatory Brief

An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

21 CFR 820 is the FDA federal regulation that pertains to quality systems for medical device manufacturers. It defines design controls and quality processes at all stages of device development in order to ensure that all medical devices marketed in the United States are safe and effective. Read our free regulatory brief for a background on the regulation and requirements for compliance.

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An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

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