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
- Go through the checklist to identify needed changes in your system and records.
- 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.