The CE-mark of a medical device (EC-certificate) is the basis for marketing in the EU. The advantage of the CE-mark is, that this single certificate allows marketing in all member
The pandemic of the Corona virus affects all of us and especially medical devices are currently the most important aid for patients. To prevent shortages of medical devices for the
The new EU Medical Device Regulation (MDR) and In-vitro-diagnostic Medical Device Regulation (IVDR) have been published in the Official Journal of the European Union. The new Regulations will enter into
The, for quite some time awaited, new version of DIN EN ISO 13485 has now come out. It differs in many respects from the previous standard. Therefore, changes of your
YES Medical Device Services GmbH is a dynamic start-up company that in recent years has become a leading service provider for questions related to regulatory affairs and quality management of medical devices. Highly qualified, highly
In September a renewed draft the new Medical Devices Regulation was presented, which will replace the existing Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on active implantable medical devices.