Eisner Safety Consultants: Qmed Qualified Supplier

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 IV bag) after a knee joint infection that I had to have emergent surgery & […]

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 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of […]

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 ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 + Amendment 1:2012 (Edition […]

World-Wide Medical Device Regulatory & Standards Updates

Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards […]

FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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 provided in a premarket submission to support a claim of Electromagnetic compatibility (EMC) for electrically-powered […]