✔️Understand the expectations of a PMS plan with an implementation guide
✔️ Concrete examples of use for each sections / PMS requirements
✔️ Pre-designed sections and tables for your medical device to use
✔️Concrete collection and analysis methods to ensure regulatory compliance
✔️ Access a fully editable Word document (.docx) to help streamline how you write
The following page is a sample
For each section required in the PMS plan template by MDR 2017/745 you will find :
🟦 Referencing MDR 2017/745 to help understand and clearly identify requirements
🟩 An insert to guide you in your thinking and to explain in a clear and concise way what is expected in the PMS plan
✅ 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.
Read our Implementation Guide to find out more about how we analyse and collect PMS data.
Don't miss any more regulatory requirements related to PMS. Our template covers all regulatory requirements.
Plan your entire post-market surveillance and benefit from exclusive annexes guiding you in planning and data collection
PMS Plan implementation guide (.docx) 47 pages
PMS plan template (to be completed) (.docx) 20 pages
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