Medical Devices – Page 2 – Eisner Safety Consultants

Insider’s look at the IEC 60601 Amendments: detailed guidance from committee member responsible for changes

It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape. With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that

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

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 (Note this service is not offered anymore please contact us with your questions.) Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC

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

FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”. The Guidance was developed to describe the types of information that the FDA expects to be