CE-marks for medical devices – Conformity to the MDR

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 MDR and COVID-19 – Moratorium of the MDR decided!

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

We relocated

Now you find us at: YES Medical Device Services GmbH Am Houiller Platz 4 (entrance A, 4th floor) 61381 Friedrichsdorf Germany phone: +49 (0) 6172 2655 900 facsimile: +49 (0)

Medical Device Regulation – final version published

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 new DIN EN ISO 13485: 2016 is there!

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

New Medical Devices Regulation

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.