✔️Risk management procedure according to ISO 14971
✔️ Clear link with post-market surveillance & clinical evaluation
✔️ Flowchart & process explained
21 pages (.docx), digital download
For each step & activites required in the Risk Management process by ISO 14971:2019 you will find :
The following page is a sample
✅ Concrete and precise explanations of each activity
✅ Explanatory flowcharts
✅ Links to quality & regulatory process
A full process covering all levels of ISO 14971