The implementation deadline of EU MDR 745/2017 is 2020. This webinar will help you learn how to quickly implement it in a simple way and pass the Quality Management Audit by your certification company or notified body. It covers the topic of supply chain and the interfaces to the EN ISO 13485:2016.
One of the hot topics of the new medical device regulation EU MDR 745/2017 in the European Union is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Additional activities are required by both the ISO and the MDR. Care should be exercised with outsourced processes. These activities are both on the classic supplier side and on the other side of the company in the field of sales and post market activities. It is important to understand these changes to keep your certificates ready and prevent doing them in the last minute.
This webinar will help you understand what changes are made to the new medical device regulation EU MDR 745/2017 in the European Union, how to implement them into your existing quality management system in a quick and simple way. The webinar will provide smart ideas to pass the quality management audit by your certification company or notified body within the short timeline.
The webinar will describe the following vital topics:
CEO’s, purchasing manager, quality/regulatory affairs manager, quality representatives of
Senior Expert Medical Devices, Frank Stein healthcare projects
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
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