Eisner Safety Consultants: Qmed Qualified Supplier

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, […]

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 […]

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) […]

RAPS & Medicaldeviceslegal.com EU Medical Devices Regulation Chart

This Regulation Chart & the blog post contents is Thx to Medicaldeviceslegal.com and the RAPS Dutch/Flanders chapter.  We are grateful to them for sharing such a valuable tool and hope you get a lot of good use from it too.  All they ask you do is to provide them with feedback if you have ideas of additional […]

Impact of the Draft report on the EU MDD proposed regulations

This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some […]