CE marking of Medical Devices according to 93/42 CE directive

For class IIa, IIb and III, the regulatory path called annex II "Full Quality System" is primarly selected by manufacturers.

Before obtaining the right to CE mark, the manufacturer must obtain an ISO 13485 certification delivered by a notified body. 

Our contribution:

• selection of the adequate regulatory scheme and notified body
• identification of applicable standards
• analysis of essential requirements 
• development of a verificaiton and validation plan
• development of the quality management system (QMS)
• design of the clinical strategy
• risk-management according to ISO 14971
• documentation of technical file according to NB-Med recommendations