What is changing with the new 14971:2019?

ISO 14971:2019 is one of the major standards for the Medical Device Industry after ISO 13485. So it was really interesting to create this LinkedIn Live with Marcelo Antunes to go through the changes.

Marcelo did first provide an overview of the ISO 14971 creation process to make people understand the time needed to make it release. The context was also important as some of the changes were needed to be aligned with the MDR or IVDR and some other standards.

We went through each chapter to present the major changes. There were also some changes that were not clear or even necessary. What we discovered during this presentation is the misunderstanding regarding the usage of a Standard. Marcelo even said that people can evaluate Medical Device Risks without using this standard. They are still able to prove that their product is compliant.

Some questions during the Live were really interesting. This is also the reason to have a live session. Marcelo was really helpful to make people understand the interpretation of each change.

Don't hesitate to look at the replay below. And continue to ask your questions in the comment section.

You want to buy ISO 14971 check it here.