News

New member | IRICE

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.

contact@iri-ce.fr