General
Notification of Changes (QM Standards) Notification of Changes - MDD/IVDD Notification of changes - MDR 2017/745 Notification of changes - IVDR 2017/746 List of critical suppliers…
”mdc medical device certification“ stands for safety and quality in the sensitive field of medical devices and healthcare. Our experienced staff of more than 150 employees and 70 external…
Lists of valid certificates
EN ISO 13485 EN ISO 9001
List of withdrawn and suspended certificates
Withdrawn and suspended certificates
List of forged certificates
Forged…
Liste Zertifikatsfälschungen / List of forged certificates Nr. 1. 2. 3. Zertifikatsnummer Certificate number 0483/D1263400015 _AM_PHARMA_RL_ fake 0483/HRB48209_AT C_Medical_Technic s_GmbH_fake …
Structure of Technical Documentation (Medical Devices) 005/10.2023 ID: 2379 The following structure is based on Regulation (EU) 2017/745 (MDR) but is also suitable for technical documentation…
The management of mdc declares the following on behalf of the entire top management:
Not only legal and normative requirements, but the general character of our activity as a Notified…
Application for Certification according to QM Standards 027/09.2023 ID: 414 After being checked and signed by mdc this application is a valid Certification Contract between mdc medical device…
Process Description Certification of Quality Systems 1. Introduction Subject of this process description is the certification of quality management systems ( called quality system in the following)…
Rules for certification procedures according to Regulation (EU) 2017/746 1. Subject The present certification rules are a component of the General Terms of Business of mdc medical device…
Application for Certification according to Regulation (EU) 2017/746 003/09.2023 ID: 5752 After being checked and signed by mdc this application is a valid Certification Contract between mdc medical…