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    August 1, 2022
    Are you performing your CAPA effectiveness check?

    According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each […]

    July 15, 2022
    Have you established acceptance activities for your medical devices?

    According to the Code of Federal Regulations (21 CFR 820.80 Acceptance Activities), each manufacturer shall […]

    July 1, 2022
    Do your OOS Investigations include root cause evaluation and follow-up?

    According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]