Regulations in the medical device industry require medical device manufacturers worldwide to implement an effective quality management system. ISO 13485:2016 - or the German version of this standard, which will be published in 2021 as DIN EN ISO - is an international standard that is recognised in almost every country in the world. The two annexes ZA and ZB of the German and European standard are linked to the key legislation in Europe - the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) - and provide an overview of where ISO 13485 covers the legal requirements.

Successful implementation of this standard is only possible with a well-trained medical device quality management staff. Investing in this training will provide real added value and ensure acceptance within your organisation.

Our 5-day training course for medical device quality management professionals according to ISO 13485:2016 will familiarise you with the regulatory principles of medical device quality management. You will become familiar with the regulatory environment of the current MDR/IVDR in which the standard is embedded. We will show you how to meet the requirements of ISO 13485:2016. We will present the structure, content, scope and exemptions of ISO 13485 and provide you with the knowledge you need to successfully support the QM system. You will learn the steps you need to take to process and document your medical device from inception to launch. You will work in groups to develop solutions for the practical implementation of your quality management system. 

The seminar is part of a modular training programme and forms the basis for the further qualification to become a Quality Management Representative (QMB) or a Quality Auditor. TÜV SÜD Akademie offers you tailor-made options for this.