Regulatory & Safety Experts for Global Medical Device Approvals
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
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
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
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
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