Why Should You Attend:
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 requires for outsourced processes additional activities and be careful with outsourced processes. 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. The understanding of this changes and how to implement is essential to keep your certificates.
You should attend this webinar to understand, what are 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 need 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 about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities.
- Explaining of 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 required?
- 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
SpeakersDr. 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.
Who Should Attend
CEO’s, purchasing manager, quality/regulatory affairs manager, quality representatives of
- medical device manufacturer
who work with European Union, European Economic Area, Switzerland, Turkey