Browse by topic
Subscribe to our news

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. 
Read Now

News

Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

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.
Read Now
1

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!