02
Services / Products
Medical Devices
-
Regulatory strategy and access to market
-
Implementation and maintenance of the quality system
-
Compliance
with the new
European
regulationEuropean Regulation 2017/745
Notified body, CE marking -
Clinical trials
Service expected/rendered (SA/SR)
-
Clinical
investigationsClass I, IIa, IIb and III
Safety and performance -
Medico-economic evaluations
Post-market surveillance plan
Real-life study (conditions of use, impact measurement, etc.)
MDR
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.
