Medical Devices Risk Analysis

Risk Analysis Medical Devices

This risk analysis (in XLS) contains the safety requirements of the Medical Devices Regulation (EU) 2017/745.

The document consists of 4 tabs:

• Front cover
• Legend (with information about the risk calculation)
• A sheet with safety requirements
• and a risk calculation sheet

Course: How to use the XLS risk analysis

If you're unfamiliar with performing a risk analysis, we've developed a video course that explains the use of risk analysis in XLS step by step. You can order this separately if desired. After completing the course, you can also take an online exam for which you'll receive a certificate.

Need support?

We have years of experience conducting risk analyses and can, if desired, provide you with support to ensure a successful outcome. Please contact us using the form below.