Sign-up to our Newsletter

Loading...Loading...


Eisner Safety Consultants: Qmed Qualified Supplier
Print This Post Print This Post

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, [...]

Print This Post Print This Post

NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation

On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”.  He spoke on the proposed Consensus Guidance Document on EN ISO 14971:2012 that is currently being drafted by NBRG (the Notified Body Recommendation [...]

Print This Post Print This Post

NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

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) [...]

Print This Post Print This Post

Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012

UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014.  We have a great line up that day so please come join us.   To kick-off the morning for our track I will [...]

Print This Post Print This Post

OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 [...]