Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Instructor:
Frank Stein
Product ID: 706165
Training Level: Intermediate
- Duration: 90 Min
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
Fast track internal audit to approve the changes
Areas Covered in the Webinar:
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 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
Instructor Profile:
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.
Topic Background:
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement 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 since May 2021. The EU Commission publish monthly new guidance documents for deeper understanding of the requirements and to give more clarification about the expectations by authorities and notified bodies.
More Training By Experts
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- ISO 13485:2016 - What are the hot topics and changes?
- Supplier Management with the new Medical Device Regulation EU MDR 745/2017
- Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
- EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
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