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


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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 in 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 additionally implemented into the quality management system until May 2020. The time is short and immediate 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
DAY 01(10:00 AM - 6:00 PM EDT)
    • 09:00 am – 10:30 am

What are the new topics in the EU MDR 745/2017 (Summary) A brief summary of the new topics to get an overview of 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.

    • 10:30 am – 10:45 am Coffee Break
    • 11:45 am – 12:30 pm

How to create a clinical evaluation compliant to the EU MDR 745/2017 and the expectations of auditors.The MEDDEV 2.7.1 rev. 4 was implemented into the MDR and is strongly related to the pos market activities and PMCF activities. In which cases is a PMCF study required and what are the expectations of a reviewer/auditor and what are the major changes?

    • 15:00 pm – 15:15 pm Coffee Break
    • 15:15 pm – 16:45 pm

Post-market surveillance and post-market clinical follow-up activities and expectations. The MDR requires frequently reporting’s to Notified Bodies and Authorities about the safety and performance of the medical devices. How to create the reports.

DAY 02(10:00 AM - 6:00 PM EDT)
    • 09:00 am– 10:30 am

The EN ISO 13485:2016 clause 0 – 4 requirements and expectations of an auditor. The new ISO standard received a couple of updates and focus now more on regulatory Requirements from local regulations e.g. the EU MDR 745/2017. What are the updates and changes clause by clause? What are the expectations of an auditor?

    • 10:30 am – 10:45 am Coffee Break
    • 10:45 am – 12:30 pm

The EN ISO 13485:2016 clause 5 – 8 requirements and expectations of an auditor. The new ISO standard received a couple of updates and focus now more on regulatory Requirements from local regulations e.g. the EU MDR 745/2017. What are the updates and changes clause by clause? What are the expectations of an auditor?

    • 12:30 pm – 13:30 pm Lunch
    • 13:30 pm – 15:00 pm

The interfaces between EN ISO 13485:2016 clause 0 – 4 and EU MDR 745/201 The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according to the standard and the MDR. What are the expectations of an auditor?

    • 15:00 pm – 15:15 pm Coffee Break
    • 15:15 pm – 16:45 pm

The interfaces between EN ISO 13485:2016 clause 5 - 8 and EU MDR 745/2016 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.

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