This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012.
On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter to industry to ask for their participation in a short survey (about 10 minutes long) to help the Notified Bodies understand what are industry’s current practices when it comes to conducting Risk Management Process on their medical devices and IVD’s and how it relates to EN ISO 14971:2012. As the letter says it is to “attempt to develop a practical interpretation on how to use and implement Risk Management in the context of the European Medical Devices Directives, more specifically the European version of ISO 14971:2007, as published in EN ISO 14971:2012.”
Please join in on this survey, as the more participation the more representative the data will be to the Notified Bodies and hopefully this will make for a better Consensus Document on EN ISO 14971:2012 Risk Management Process. Please complete your survey responses by 21 March 2014.
To find out more about what is going on with this proposed Consensus Document please join me, Leo Eisner as the track chair for Improving Risk Management Strategies and Procedures, at the MD&M West conference on Tuesday 11 February 2014, as I discuss how we got to this point and what is hopefully going to culminate in a Consensus Document on Risk Management with regard to EN ISO 14971:2012.
If you have questions about this topic or need help with compliance with your Medical products you can e-mail Leo Eisner at directly or call Leo at 503-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.