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