Tag Archive for medical device

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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Design Change: How Does FDA Define It?

Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…

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CAPA Data: What Can FDA Request to See?

Q: It’s my understanding that during an FDA audit of a pharmaceutical company, the Agency can request to see CAPA data from internal audits — but if you’re a medical device company, it can’t. Is that correct? Also, can the FDA request to see…

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