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. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.Why Should You Attend:
This webinar will provide an in-depth understanding into the following
Introduction, who must apply the new EU MDR 2017/745 requirements?
Overview about the changes of the EU MDR 2017/745 regarding quality management
What is the relationsship between the EN ISO 13485:2016 and the EU MDR 2017?
Which new requirements of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016?
The Role of the new harmonized version?
Smart and fast ways to implement the changes in your quality management system
How work the regulation and the EN ISO 13485:2016 together?
New and updated processes required by the EU MDR 2017/745
How to implement the required changes until May 2020?
Who Will Benefit:
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
Medical device manufacturer
Importer
Distributors
Dealers
who work with European Union
Organized by:
ComplianceOnline
Invited Speakers:
Frank Stein Senior Expert Medical Devices, Frank Stein healthcare projects
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, medical software, international project and regulatory consulting experience in Europe, North America, Asia, Australia, Latin-America.