Regulatory strategy and access to market
Implementation and maintenance of the quality system
with the new
European Regulation 2017/745
Notified body, CE marking
Service expected/rendered (SA/SR)
Class I, IIa, IIb and III
Safety and performance
Post-market surveillance plan
Real-life study (conditions of use, impact measurement, etc.)
MDR requires manufacturers to provide
sufficient clinical evidence
on product compliance with general safety and performance requirements.
In this context, we propose a service offer based on listening, analysis of needs and advice for any type of medical device.