Medical Devices
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Regulatory strategy and access to market
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Implementation and maintenance of the quality system
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Compliance
with the new
European
regulationEuropean Regulation 2017/745
Notified body, CE marking -
Clinical trials
Service expected/rendered (SA/SR)
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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.
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