Eisner Safety Consultants: Qmed Qualified Supplier

Free Webinar – What You Need to Know About Medical Electrical Standards Updates

Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a webinar “What You Need to Know About Medical Electrical Equipment Standards Updates (& How They Affect Your Regulatory Strategy)” December 19, 2016 1PM ET/10AM PT. […]

EU MDR & IVDR Have Been Published in OJEU 5 May 2017

Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were  Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two: Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 Bassil Akra of TÜV SÜD […]

IEC 60601-1, 3rd ed. + A2 Anticipated ’19 – Annual Standards Trends Reports Web Special

Updated April 30 to extend Web Special til end of May ’17 Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom […]

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 […]