Validation is a required component of medical device quality assurance and is essential for complying with FDA requirements. But medical device manufacturers new to CMMs aren’t always sure how to achieve FDA compliance. How can you speed up the integration time of your new quality assurance system without creating production bottlenecks? ZEISS Industrial Quality Solutions has established guidelines and validation methods from extensive research to comply with FDA standards, including 21 CFR Part 11 and 21 CFR 820.
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