MEDCERT: Application for the Designation as Notified Body under the MDR – Medical Device Regulation

We are pleased to inform you that MEDCERT submitted its application for the designation as a Notified Body under the Medical Device Regulation (MDR) 2017/745 on November 26, 2017, the earliest possible date.

Within only 6 months we have established a new QM-System of approximately 200 documents for the conformity assessment of medical devices under the MDR.

• EU: DELTA-Checklist ISO 13485:2016
• „Consequences of the Medical Devices Regulation (MDR) for Notified Bodies and Manufacturers” Interview with our Managing Director, Klaus-Dieter Ziel for the MPJ- Journal for Medical Devices
• MEDCERT: Merry Christmas!
• EU: Designation Process for Notified Bodies under the MDR
• EU: EU Commission updates its lists of harmonized standards
• MEDCERT: Application for the Designation as Notified Body under the MDR – Medical Device Regulation