✔️A template with pre-designed sections and a table for presenting and discussing your risks
✔️A complete benefit/risk analysis worksheet to determine your device's B/R profile
56 pages (.docx), digital download
For each section of the Risk Management Report 9 you will find :
The following page is a sample
🟦 A way of presenting your risks, analysing them and thinking about them using our methodology according to ISO 14971:2019.
🟩 An insert to guide you in your thinking and to explain in a clear and concise way what is expected in the Risk Management report
✅ Pre-defined sections and tables that can be modified or left unchanged for your Risk Management Report
A 5-part methodology:
✔️ PART 1: Assessment of benefit(s)
✔️ PART 2: Assessment of risk(s)
✔️ PART 3: Assessment of Benefit-Risk
✔️ PART 4: Benefit-Risk Summary
✔️ PART 5 : Evaluation of acceptability of the benefit/risk profile
+ Bonus Annex "Assessment of the benefits of devices"
We have combined and revised several methodologies (FDA, MEDDEV, etc.) to develop a robust worksheet that allows us to draw relevant conclusions about the acceptability of a medical device's benefit/risk profile.
Easily write your risk management report and benefit/risk analysis