Eisner Safety Consultants: Qmed Qualified Supplier

EU MDR & IVDR – Final Versions – Are You Ready (Updated 7, 12, & 17 March ’17)

Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources.  Check out our updates in this LinkedIn Article. Updates are all underlined: Mar 7, ’17 updates: * addition of the EU Council vote & date of release of final text * an important change that manufacturers […]

EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon

Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.  You should be starting your quality planning now if you […]

NBRG Risk Mgmt Draft Consensus Paper on Interpretation & Application of Annexes Z in EN ISO 14971:2012

Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that […]

BSI White Paper on Generating Clinical Evaluation Reports

Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports White Paper on Generating clinical evaluation reports This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how […]

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 […]