With the PMS for your device, manufacturers are obligated to fulfill extensive requirements. Application problems or previously unknown complications are to be identified in order to guarantee users and patients the best possible safety and performance of the product. The Medical Device Regulation (EU) 2017/745 requires active PMS measures and extended documentation, which occupy time and resources.
novineon CRO brings clinical systematics to your measures for active PMS. Together with you we will develop a PMS strategy that meets all regulatory requirements. Our long-standing experience in the approval and recertification of medical devices allows us to offer competent, quick and pragmatic support.
In close cooperation with you, we will prepare the necessary plans and reports, including clinical PMCF measures.
The results of today's PMS are the basis for tomorrow's clinical evaluation
We at novineon CRO do not view PMS in itself, but in relation to the technical documentation of your medical device. Therefore all our documents are modularly structured so that they can be updated or integrated quickly and easily.
Based on a joint research project in the field of artificial intelligence with OntoPort UG, we have developed a system for automated PMS.
We at novineon CRO now offer this highly innovative solution, the OntoPMS system, to our customers. OntoPMS software is especially interesting for large product portfolios. The IT system based on ontologies allows you to automatically capture and document the manifold data sources on the internet that are relevant for comprehensive PMS. Learn more.
Contact your novineon specialist.
Phone: +49 7071 98979 – 127