✔️ Risk management plan according to section 4.4 of ISO 14971:2019
✔️A robust risk analysis methodology
✔️ Indicators & threshold for PMS/trend reporting
✔️ Flowcharts, matrices and full methodology explained.
37 pages, digital download
For each section required in the Risk Management Plan by ISO 14971:2019 you will find :
The following page is a sample
🟦 Referencing ISO 14971:2019 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 RMP plan
✅ Pre-defined sections and tables that can be modified or left unchanged for your Risk Management Plan
Meets the requirements of ISO 14971:2019 and the regulatory requirements of the MDR 2017/745.
✔️ Risk management plan according to section 4.4 of ISO 14971:2019
✔️Full risk management methodology according to ISO 14971:2019
✔️ Matrices & decisions flowchart for risk management
✔️ Indicators & treshold for PMS & trend reporting, according to MDR 2017/745
We have created 6 Annexes of decision flowcharts & worksheet to support the risk analysis methodology.
Easy to understand and implement, these appendices will help you implement a complete methodology.