Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation


Instructor: Frank Stein
Product ID: 706532
Training Level: Intermediate to Advanced

  • Duration: 90 Min
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.
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Why Should You Attend:

You should attend this webinar to understand the requirements of EU MDR 2017/745 Article 15. This article requires a new role, named Responsible Person for Regulatory Compliance. The role is new, requires a regulatory background, and scientific education in the defined scope by the regulation or alternative a couple of years experiences with the European Regulation. You learn in this webinar the tasks and obligations of this new role, the required education and professional background, and the processes, who need an update.

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 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 manufacturers
  • Importers
  • Distributors
  • Dealers

who work with European Union

Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

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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