Biotech / Pharma
Digital Health
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.