Why Should You Attend:
This webinar will provide an in-depth understanding into the following
You might also wish to attend our comprehensive One-Day Virtual Seminar on Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation
Areas Covered in the Webinar:
Who Will Benefit:
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
who work with European UnionInstructor Profile:
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.
The regulation EU IVDR 2017/746 in the European Union has many new requirements. This regulation is also stronger connected to the EN ISO 13485:2021. The understanding of the changes regarding the previous regulation and how to implement is essential to keep your certificates up to date.
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 IVDR 2017/746.
The second key is to understand, which parts of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2021. These not covered paragraphs and requirements must be additional implemented into the quality management system.
The EU Commission publish monthly new MDCG guidance documents for deeper and more detailed understanding of the requirements and to give more clarification about the expectations by authorities and notified bodies.
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