13 January 2021
Jeanne Chamousset-Roman is Consultant in Regulatory Affairs and Quality Management in MEDICAL DEVICES supporting companies for various procedures:
- Regulatory positioning of products / services (classification of medical devices, software, etc.)
- CE Mark obtention
- Regulatory approbations for other territories (US, Canada, Australia, Brazil …)
- Implementation of a Quality Management System
- Certification projects (ISO 13485, MDSAP….)
- Preparation for audit / inspection
- Training in Regulatory Affairs and Quality Management
Support can also be provided through training and skills transfer on these different subjects.