ISO 14971 Medical Device Risk Management Training


Instructor: Frank Stein
Product ID: 706564
Training Level: Intermediate to Advanced

  • Duration: 3 hrs
This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.
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Why Should You Attend:

You should attend this webinar to understand, what are the changes to the previous ISO 14971 and how to implement the changes in your risk management file in a simple and quick way. Your implementation time can be shorter with a good plan and approach and need smart ideas to reach the right level to pass the expectation by your certification company or notified body.

Learning Objectives:

In this course, you will:

  • Learn Who must apply the new ISO 14971:2019 requirements
  • Get an overview about the changes of the ISO 14971:2019 regarding technical documentation processes and product life cycle management
  • Learn What are the interfaces between the ISO 14971:2019 and the EU MDR 2017
  • Smart and fast ways to implement the changes in your technical documentation and risk management file.

Areas Covered in the Webinar:

  • The Scope of the ISO 14971:2019
  • The interfaces to the EU MDR 2017/745
  • New and updated processes required by the ISO 14971:2019
  • How to implement the required changes and how to update the risk management file?

Who Will Benefit:

Product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • medical device manufacturer,
  • medical device OEM/PLM
  • EU Representatives
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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