I have to perform a clinical evaluation of my medical device (MD). How do I do this?
The approach is to follow specific guidelines and mainly MEDDEV rev3 2.7.1 and Directive 93/42 EEC Annex X! But this is not quite as simple… Should I do a clinical trial? Then do I settle for the literature?
With nex’med you have:
- In-depth reflection upstream which allows you to avoid embarking on a clinical trial when it is not necessary;
- Step-by-step accompaniment to help you understand and draft a report;
- Structured and facilitated reading is an important added value for the assessment of the final file by the notified bodies;
- The final report is very clear and objective. It is also closely linked with post-market surveillance and risk management, and ensures the safety and performance of marketed devices;
- Expert support in case of specific questions.
What happens in case of non-compliance?
In case of non-compliance, the notified body raises non-conformities and the device cannot be marketed, leading to significant financial losses due to an incomplete file.