Clinical Evaluation

For clinical evaluations that meet the expectations of notified bodies

Services and expertise > Clinical & reimbursement > Clinical Evaluation

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Contact Mathieu CHARLEUX on :+33 6 03 17 92 45

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Clinical & reimbursement

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Qualified writers, a customized solution

Clinical evaluation must be carried out throughout the device’s life cycle, and European regulations require that clinical evaluations be periodically updated and that post-market clinical follow-up (PMCF) must be implemented by medical device manufacturers.

MD101 offers full support in this process :

  • Drafting of your scientific state of the art.
  • Definition of the clinical evaluation strategy.
  • Update your clinical evaluation plans and reports.
  • Drafting of your clinical evaluation plans and reports in accordance with the requirements of EU Regulation 2017/745 and current MDCG guides.
  • Drafting of your post-marketing clinical follow-up plans and reports (PMCF).
  • Critical review of your clinical evaluation plans and reports to ensure compliance with regulatory requirements if they are internally written by your teams.

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

Catalyzing global growth and innovation

MD101, founding member of The MedTechAlliance, USA