Clinical Investigations

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!

© 2019 MEDIACC GmbH