ISO14971:2019 Webinar.  This Webinar was presented December 16, 2021.

Did you miss the webinar? No problem, you can download the presentation slides here.  We ask that you please give credit to Exemplar Compliance and Greenlight Guru when reposting or presenting. Download The Webinar Slides Here.



Risk Management is an integral part of any Quality System, yet companies are struggling to keep up with regulatory updates and the impact on their QMS.

Significant changes in the regulatory climate have shifted to risk-based processes, providing a greater emphasis on the Risk Management files for medical related products.

ISO 14971:2019 Medical devices — Application of risk management to medical devices

EN ISO 14971:2019 is NOT harmonized (as of December 2021), but it is considered to be a “state of the art” standard and should be used in place of earlier editions.

The processes described in ISO 14971 assists manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

This presentation was originally presented as an interactive session covering the key changes to ISO 14971 and practical approaches for implementation of the new standard for both new products and legacy products.

Learn about the key updates to ISO 14971:2019 and hear insights from other companies implementing the revised standard. Explore best practices for updating risk documentation and staying compliant with international standards.


  • How ISO 14971:2019 applies to your company
  • Key changes from prior versions of the ISO 14971:2019 Standard
  • Key timing for implementation of updates across different global requirements
  • Tips for creating the Risk Management file for new products
  • Tips for updating legacy Risk Management files to current standards
  • Effectively evaluating Risk Management files during design change
  • Effectively evaluating Risk Management files and incorporation of Post-Market Surveillance information



Want more information about the cloud based software used to identify, evaluate, and manage risk?  Checkout Greenlight Guru.


Want more information on developing a Quality System, implementing risk-based processes, or working towards product approval?  Contact Exemplar Compliance.




Exemplar Compliance is a full service consulting firm providing practical quality solutions to the medical device, IVD, Pharmaceutical, and biologic industries.  We work closely with customers to implement solutions that meet their business needs.  We support our clients in all aspects of the product lifecycle from new product development to full commercial scale-up.  Our specialists have experience in Quality, Regulatory, Product Import, Quality Audits, and Computer System Validation.  Give us a call today and let’s chat about your next project.

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