Medical Device Risk Management - Medical Devices Group

Consultant

November 2016

< 1 min reading time

Just had an article referred to me about ISO 14971 that we all should read. It was a written by an academic researcher in product safety risk management and discusses the merits of ISO 14971.

https://onriskof.com/2016/10/03/medical-device-risk-iso-14971-gets-it-right/

source: https://www.linkedin.com/groups/2070960/2070960-6200380090652590080

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Posted by Edwin Bills, ASQ Fellow, RAC

Asked on November 4, 2016 12:00 am

54 views

like 4 comments

	Private answer Ed - I read this article too. I found it very enlightening. For me, hearing the objectivity of the author who has no medical device experience was very encouraging. The author touted the work you and others have done with ISO 14971 as a model for risk management. Marked as spam like Report spam
	Private answer Mark Swanson While I like the concepts brought forth in 14971, it is time for a revision to align with the risk based approach and other current thinking on medical device risk. Marked as spam like Report spam
	Private answer Dr. Patrick Druggan Mark Swanson, MBA, ASQ CBA, CMQ/OE & CQE, can you expand on your comment. I've used ISO14971 in the EU and I am interested in hearing the perspective from the USA Marked as spam like Report spam
	Private answer Ruud Lans Its a great article. I just used it today. Certainly useable in the US Marked as spam like Report spam

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