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:
- 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
- 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.
Please feel free to contact us by mail or telephone!
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