This service is carried out according to the following methods:
- Familiarisation with your products, your regulatory environment, your distribution countries
- Installation of the dedicated legal and regulatory framework in an Excel file
- Setting up of monitoring based on the validated framework
Once the first framework has been established, we ensure watching of your standards, guidelines and regulations:
- Standards, guidelines and regulations
- French regulations
- Watching from the Journal Officiel (any new publication on laws, decrees, orders, circulars, decisions, and notifications relating to medical devices and IVD and their eventual cover by French Social Security).
- Watxhing from the ANSM website (any modification, update on General Information, the main legislative and regulatory texts, specific procedures, the main interpretive text, the traceability of medical devices, information updates from ANSM, information relating to vigilance
Any new standard or any new text will give rise to:
- The updating of the framework
- The provision of a monitoring sheet with:
- The context
- The analysis of the text
This service is subject to an annual set fee.
On your request, we also carry out this monitoring in all the countries where your devices are sold.