Clinmark experienced team supports formulation of regulatory strategies and study designs of medical devices and in-vitro medical devices in all kinds of indications. The entry into force of the Medical Device Regulation (MDR) 2017/745 and the In-Vitro Medical Device Regulation (IVDR) 2017/746 result in changes to the existing requirements for medical devices. The new regulations apply to clinical trials necessary to introduce products to the market as well as post-marketing studies. Also, the recertification of products already present on the market may require new clinical trials in accordance with these regulations.

We will help you to set up a clinical trial tailored to your medical device-specific needs and support you at each step:

  •  Selection of the appropriate regulatory pathway for a given medical device
  •  Clinical strategy/Study design
  •  Medical writing
  •  Feasibility process
  •  Submission of the application for conducting clinical trial to EC and RA
  •  Interactions with Regulatory Authorities, EC and notified Bodies
  •  Clinical data management
  •  Clinical project Management
  •  Monitoring
  •  Safety – vigilance and reporting
  •  Biostatistics

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