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.

Before the market

• Advice on clinical strategy, bibliographic analysis
 
• CE pre-marking clinical investigations :
Medical writing, methodological and statistical advice
(investigation plan, information note, observation book, investigator brochure, etc.)
Regulatory submission, contract management
Operational implementation
(monitoring of investigation centers, monitoring, administrative support, inventory management, etc.)
Materiovigilance
Data management
Data analysis
Valuation of results
 
• Writing of the clinical evaluation plan / report (CEP / CER), of the post-marketing surveillance plan (SAC or PMS) / post-marketing clinical follow-up plan (SCAC or PMCF)
 
• Claims for reimbursement (CNEDiMTS)

Retention in the market

  • Advice on clinical strategy
  • Post-CE marking clinical investigations
  • Practice surveys, retrospective studies (databases)
  • Updated clinical assessment plan/report, PMS/PMCF plan
    Writing PMS / PMCF reports