Past event: Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation Virtual Seminar

2-Day Virtual Seminar Through WebEx

Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement last minute changes until May 2021 is essential to keep your certificates. The first key for the understanding and the implementation of the changes is the knowledge about the interfaces between the EN ISO 13485:2016 and the EU MDR 2017/745. The second key is to understand which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2021. The time is short and immediately action is required.

Learning Objectives :

  • 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 are the interfaces 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?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes

Areas Covered :

  • The new scope of the EU MDR 2017/745
  • The obligations and roles of the EU MDR 2017/745
  • 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 2021?

Who will Benefit:

  • CEO' s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
  • medical device manufacturer,
  • importer,
  • distributors
  • dealers

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive - Here' s a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH

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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Time: 10:00 AM to 6:00 PM EDT

Venue

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Event details
Organizer : ComplianceOnline
Event type : Training Course
Reference : ASDE-23007