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 last minute changes until May 2020 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 time until May 2020 is short and 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:
Areas Covered in the Webinar:
Who Will Benefit:
CEO's, Quality/Regulatory affairs manager and quality representatives of medical device manufacturer, importer, distributors and dealers who work with European Union.Instructor Profile:
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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