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
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 ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015 (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC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