Procedure for Post-Market Surveillance System

The purpose of this procedure is to provide a post-market surveillance system so that the organization can know at all times what happens to medical devices once they go out of production.
This procedure describes the systematic gathering, recording and analyzing of relevant data on the quality, performance and safety of a device throughout its entire lifetime.

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There are 4 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Post-Market Surveillance Plan, Post-Market Surveillance Report and Periodic Safety Update Report.