The medical device regulation EU MDR 745/2017 in the European Union has a lot of requirements. This regulation is also stronger connected to the EN ISO 13485:2021. The first key for the understanding and the implementation of the changes is the knowledge about the relationship between the EN ISO 13485:2021 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 13485:2021. These not covered paragraphs and requirements must be additional implemented into the quality management system.

Learning Objectives :

  • Introduction, who must apply the EU MDR 2017/745 requirements?
  • Overview about the changes of the EU MDR 2017/745 regarding quality management
  • What are the relationships between the EN ISO 13485:2021 and the EU MDR 2017?
  • Which requirements of the EU MDR 2017/745 are not covered by the EN ISO 13485:2021?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes

Areas Covered :

  • The 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 13485:2021 together?
  • Processes required by the EU MDR 2017/745

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
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • Certification

Who will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • medical device manufacturer,
  • importer,
  • distributors
  • dealers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

July 19, 2022 (9:00 AM to 4:00 PM PST)

  • 09:00 – 09:45: What are the topics in the EU MDR 745/2017 (Summary)
    A brief summary of the topics to get an overview about the MDR. The focus is performance and safety. Both need to be approved by verification and validation actions in pre-clinical activities (physically, chemically and biologically lab tests) and in clinical study activities or clinical evaluations. The risk classes and the regulatory pathway for high risk products changed.
  • 09:45– 12:30: The new route of the conformity assessment under EU MDR 745/2017 and the expectations of auditors
    What is new in the conformity assessment and what are the consequences for the time line, for the budgets and the organization of the activities to create a technical file according the MDR. Risk class III and IIb will have additional assessments by the EU-commission. This expand the time to market.
  • 12:30 – 13:30: Lunch
  • 13:30 – 14:30: The relationships between EN ISO 13485:2021 clause 0 – 6 and EU MDR 745/2021
    The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR. What are the expectations of an auditor?
  • 14:30 – 16:00: The relationships between EN ISO 13485:2021 clause 7 - 8 and EU MDR 745/2021
    The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR.
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Frank Stein

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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