Module 16 2024

17/10/2024

The post market surveillance plan

8) Corrective and preventative action processes:

The PMS plan shall cover…

Annex III, 1.1(b), Indent 8 - Systematic procedures to identify and initiate appropriate measures, including corrective actions;

CAPA procedure – Procedure for managing corrective and preventative action

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The post market surveillance plan

9) Product traceability:

The PMS plan shall cover…

Annex III,1.1(b), Indent 9 - Effective tools to trace and identify devices for which corrective actions might be necessary;

Product traceability procedure – Procedure for managing corrective and preventative action

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