ISO 14971 Medical Device Risk Management Training

Instructor: Frank Stein
Product ID: 706564
Training Level: Intermediate to Advanced
  • 19
  • November 2020
  • 07:00 AM PST | 10:00 AM EST
    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.

Live Online Training
November 19, Thursday 07:00 AM PST | 10:00 AM EST | Duration: 3 hrs

One Dial-in One Attendee
Purchase using Webinar All-Access Pass
(One user get unlimited access to all upcoming and recorded webinars (350+) for one year)

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version


Live + Training CD/USB


Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

Follow us :
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Managing Your Complaints and Obstacles in Post-Market Requirements

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed