EN ISO 14971:2019 A11:2021 has been released by CEN to European standards providers and should be available soon. CENs website indicates they expect it to be published in the OJEU as a Harmonized Standard.
I will be presenting on a video meeting December 15 with the details. The meeting is shown at Upcoming Events on AAMI Main Page
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| The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission-the development, management, and use of safe and effective health technology. |
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal Consultant
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