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An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Standard’s Working Group

A session by Ed Bills, ASQ Fellow, RAC and Tom Rish
Greenlight Guru

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About this talk

The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.

The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.

These may include simple reference changes in procedures, or revision to production and post-production processes that may be required.

Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.


• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.

• Reasons for the changes to the latest version

• How to prepare for the coming changes in the standard

And more!

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