Tag Archives: Dr. Christopher Devine

Devine Guidance

MHLW MO 169 – Chapter 2/Section 6 – Preventive Action

By Dr. Christopher Joseph Devine
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Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.

Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.

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