Industry News – Page 17 – Eisner Safety Consultants

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

Global Medical Device Regulatory & Standards Updates

Enjoy our Second global standards & regulatory update. It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition

IEC 60601-1-9 required for Brazil Near End of 2016

Brazil IEC 60601-1-9 required Near End of 2016 – Are You Ready? ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015 (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC

Need Help with Your Medical Device – See You in SF Bay Area End Apr & San Diego Early May ’16

Are you in the process of designing a medical electrical device or need some help in meeting IEC 60601-1 and related standards? Do you need help with a medical device regulatory submission or your quality system? Also, we have a team of medical device experts

ESC New Annual Standard Reports Available by Early April ’16

(Note this service is not offered anymore please contact us with your questions.) Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical