02 Services / Products

Medical Devices

  • Regulatory strategy and access to market

    Lorem ipsum

  • Implementation and maintenance of the quality system

    Lorem ipsum

  • Compliance
    with the new
    European
    regulation

    European Regulation 2017/745
    Notified body, CE marking

  • Clinical trials

    Service expected/rendered (SA/SR)

  • Clinical
    investigations

    Class 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.

Dispositifs Médicaux

Euraxi
accompanied
for more than 10 years
DM makers
for carrying out their assessments and
clinical investigations