Module 16 2022

05/09/2022

Typical method of PMS:  Sit by the telephone and wait for complaints  If they are “serious” report them to the Competent Authority and the Notified Body

The Organisation for Professionals in Regulatory Affairs

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 Cannot sit and wait for adverse events to happen  Proactive PMS is required to be implemented per the MDR

 Saves you a lot of hassle from….  Competent authority enforcement action

 Containment  Remediation  Reputational damage

The Organisation for Professionals in Regulatory Affairs

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