MD squared obtains TUEV Certification as Manager Regulatory Affairs – Medical Devices
From January 16 to January 27 I attended a compact seminar with workshops by the academy of the Notified Body TUEV SUED on Regulatory Affairs to obtain latest updates on European and International Regulations, Directives and Guidelines in the Medical Device world.
Training and exam covered the current Medical Device Directive and upcomming Medical Device Regulation, novel Guidelines and their national implementations in the European Union
Also the Qualitymanagement System according to ISO 13485, Technical Documentation requirements for Medical Devices, their Clinical Evaluation and Riskmanagement according to DIN EN ISO 14971:2013 were part of the certification.International Regulatory Affairs included the USA, Japan, China, Saudi-Arabia, Australia, Malaysia, Singapore, Mexico, Brazil and Canada.
The first week ended with the examination and certification on European Regulations, the second week then covered International (in the sense of Non-EU) Regulations.
13 aspiring candidates prior to the TUEV exam to become Manager Regulatory Affairs - Medical Devices