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Location: MedTech Theater
Title: Confidence in Validation for CMM Inspection Processes
Event Type: Show Floor Education
Validation of inspection processes for medical components is essential for complying with FDA requirements. However, many medical device manufacturers that inspect medical components using CMMs aren't always sure what a comprehensive validation approach for these systems must include to meet FDA regulations. What does the FDA actually require when it comes to the validation of CMMs, metrology software, and inspection processes? How should medical device manufacturers approach validation in a way that is complete, efficient, and effective for their applications? ZEISS Industrial Quality Solutions has established guidelines and validation methods from extensive research to comply with FDA regulations, including 21 CFR Part 11 and 21 CFR Part 820.
