PSUR periodic safety update report
How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR
The requirement for a periodic safety update report (PSUR) or post-market surveillance report (PMSR) is new under EU MDR and EU IVDR. MDD and IVDD had post-market requirements, but the MDR and IVDR requirements are more formal, and for most classes, these reports must be updated and submitted to notified bodies (NBs) on an annual or biennial basis.
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10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.
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