With many years of experience, we support medical device manufacturers in all tasks arising for clinical investigations from Annex XV of the new EU Medical Device Regulation (EU MDR 2017/745).

We offer you the following activities in our portfolio:

  • Development of an appropriate clinical plan of investigations reflecting the latest scientific and technical knowledge as well as the underlying legal requirements,
  • Adaptation of the clinical investigation appropriate to the device under investigation,
  • Choice of concise endpoints related to the intended purpose, clinical benefit, performance and safety of your product,
  • The clinical investigation plan will be

            - in accordance with recognised ethical principles,

            - adapted to your medical device,

            - taking due account of the technical and functional features of your device, in particular those involving safety and

              performance characteristics.

  • Preparation of declarations of Informed consent taking into account the EU General Data Protection Regulation 2016/679 (GDPR),
  • In preparation of the clinical investigation we undertake

            - Request for the approval of your clinical investigation,

            - Obtain the necessary insurance for the clinical investigation,

            - Application for an ethics committee opinion until final approval,

            - Preparation of the investigators brochure for the examiners involved,

            - The instruction and training of the examiners involved,

            - Communication with the competent authorities.

  • Technical and clinical documentation in an appropriate form,
  • Further obligations of the manufacturer (sponsor),
  • Drafting the clinical investigation report.

 

Please feel free to contact us by mail or telephone!

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