Post Market Surveillance Procedure
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plans and Reports; and Post Market Clinical Follow-Up (PMCF) requirements including easy to follow documents.
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Post Market Surveillance Procedure
The Post Market Surveillance Procedure is intended to support post-market surveillance under MDR (EU) 2017/745 and ISO 13485:2016.
Post Market Surveillance System
The Post Market Surveillance Procedure helps plan, establish, document, implement and update post-market surveillance in a manner that is proportionate to the risk class and appropriate for the type of device. The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plan and Report (Includes Sample Plan); and Post Market Clinical Follow-Up (PMCF) requirements.
