Supplier Management with the new Medical Device Regulation EU MDR 745/2017

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

• Closer regulatory binding of the ISO to the new EU MDR
• Responsibilities for outsourced processes
• What are outsourced processes?
• Adjustments in the management review
• Adjustments in the audit process
• How to onboard the supplier?
• Examples from outsourced R&D-, manufacturing-, lab-test - processes
• Examples from outsourced sales processes

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Both, the ISO standard and the MDR require for outsourced processes additional activities and be careful with outsourced operations. Those are not only on the classic supplier side. Those are also on the other side of the company in the area of sales and post-market activities. An understanding of these changes and how to implement them is essential to keep your certificates.
You should attend this webinar to understand the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
The webinar will describe the following vital topics:

• Introduction, who must apply the new EU MDR 745/2017 requirements
• Overview of the changes of the EU MDR 745/2017 regarding the supplier and outsourced activities.
• Explaining each change
• Smart and fast ways to implement the changes in your quality management system
• Fast-track internal audit to approve the changes
• Who is responsible for the activities?
• Which (new) roles in the company are required?

CEOs, purchasing managers, quality/regulatory affairs managers, and quality representatives of

• medical device manufacturer
• importer
• distributors
• dealers

Prof. H.C. Frank Stein is a medical engineer, medical engineering, & has software experience for 25 years. He has clinical and research experience in tissue engineering, electrophysiology, cardiac surgery, and cardiology, industrial experience in IVD, ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project, and regulatory consulting experience in Europe, North America, Asia, Australia, Arabic countries, and Latin America.