Post-market surveillance requirements: Guidance to Manufacturers

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The document will help you understand increased post-market surveillance requirements under MDR and IVDR. 

This Guidance extensively explains notions of PMS, PMCF as well as PSUR, PMSR; but also vigilance reporting and how to prepare and be compliant with the new legal requirements.

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PREVIEW: MDR IVDR Post-market surveilllance requirements Guidance to MF

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Date of publication: January 2019