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MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

7 March 2014 – MD&DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives) and what is being done to reduce the confusion.

The NBRG (Notified Body Recommendation Group) Risk Management Working Group is working to put together a consensus document.  A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it.  Read the article for more details and a post that links to the survey.

Past posts on this subject include:

If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).