Tag Archive for medical device

Design Validation: More than Just User Testing

Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…

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Incoming Inspection: Is Pass/Fail OK?

Q: At my company, incoming inspection includes measuring the length of a cable used in our products. The results are recorded as “pass/fail”. My colleague thinks the actual results (the measurement) should be recorded instead. I can’t recall an actual regulation…

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