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

Status Update on NBRG Risk Management Consensus Document






This post is a status update on the NBRG RMWG Risk Management Consensus Document 30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because […]

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

EU Council Meets Tues 10 Dec Proposals for Med Dvc & IVD Regulations






medicaldeviceslegal.com comes through again with another fantastic post of  7 Dec 2013 by Erik Vollebregt of Axon Lawyers that is full of valuable information and is a good summary of where things stand and what is expected to happen when the EU Council meets to discuss the dossier of medical devices and IVDs revision (proposed […]