Are auditors required to be trained in ISO 14155 when auditing MD?

• Zara Ali
  04/12/2020 14:53

  Where does it state auditors are required to be certified in ISO 14155 before auditing medical device studies? If its not stated anywhere, should they be certified?
• colette McIntyre
  04/12/2020 15:04

  As 14155 is the standard for the conduct of clinical investigations for medical devices I'd say that any auditor auditing a clinical investigation on a medical device should have training on the standard, if the auditor is not familiar with the requirements of the standard how could they confirm that the investigation was being conducted to the requirements of the standard in addition to the protocol?

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