Checklist ISO 14971:2007 to ISO 14971:2019 Free

(ex. GST/VAT)

This checklist can be used to identify changes to your processes, procedures, templates and risk management records when transitioning from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019.

SKU FT-ISO14971CHK Category Tags , ,


Why is it useful

The checklist will identify some of the most commmon changes that you will be carrying out when updating to ISO 14971:2019 and save time in that process.

How to use it

  1. Go through the checklist to identify needed changes in your system and records.
  2. Review the standard for additional changes.

Need risk management training and a course certificate?

Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. Created by industry experts. Certification on successful completion of course.


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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.