22. May 2023PMS – Reports and RequirementsThe time has finally come: almost 1.5 years after the MDR came into force, the MDCG has published the long-awaited guidance document for the preparation of the PSUR.
4. May 2023Clinical Data – PMCF – Clinical Investigations of Medical DevicesMany problems lurk when collecting clinical data as part of the PMCF. We help you to create a sensible strategy.
12. July 2021Person Responsible – Implementation of Article 15 MDRAs a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.