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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
MEDICAL COMPLIANCE SEMINAR Thursday, May 18, 2017 Seminar Topics: Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada IEC 60601-1 series: Intro to IEC 60601 -1 series with Collateral & Particular Standards Design & compliance to IEC 60601-1
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
Read the recent IEC e-tech magazine article (in Oct 2016 e-tech) titled ‘Rapid growth in home use of medical devices requires new standards‘. It discusses both medical and non-medical home use devices and where standards development is going. Also, it discusses
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 on the 15 Steps to Get IEC 60601-1 Approval