FDA 21 CFR Part 820 vs. ISO 13485
· It is more similar to ISO 13485 as far as requirements are concerned. Other Parts include (for example) Part 810, which deals specifically with the procedure of medical device recall, and Part 830, dealing with unique device identifiion of medical devices. ISO 13485 and FDA 21 CFR Part 820 are compared on the basis of their purposes, histories, scopes, and influences on each other. The ...