Industry News – Page 14 – Eisner Safety Consultants

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

Rapid Growth in Home Use of Medical Devices Requires New Standards

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

15 Steps to Get IEC 60601-1 Approval – Webinar

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

Tips for Success When It Comes to IEC 60601-1 – Podcast

Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to

Home Use Medical & Wellness Devices Article by Leo Eisner

Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an