✔️Guidance using real medical product examples
✔️ Pre-designed sections, concrete examples of how to analyse and conclude to inspire your PSUR
✔️Each section clearly describes what to wear
✔️Access a fully editable Word document (.docx) to help streamline how you write.
The following page is a sample
🟦 Details of what needs to be included for each section of the PSUR
🟩For each section, there are examples of a real medical device to inspire you and to show you a concrete example.
✅ Pre-defined sections and tables that can be modified or left unchanged for your PMS plan
After several years of experience and audits, we can now offer you a template that complies with the requirements of MDR 2017/745.
Get inspired by a PSUR complete with a real medical device to help you analyse and conclude for your medical device.
Don't miss any more regulatory requirements related to PMS. Our template covers all regulatory requirements.
Create your PSUR with our pre-written sections and specific examples using our device - all you need to do is tailor it to your device!
PSUR implementation guide (.docx) 38 pages
PMS plan template (to be completed) (.docx) 18 pages
digital download