Eisner Safety Consultants: Qmed Qualified Supplier

Save $20K or more with ESC’s Annual Standards Trends Reports

Eisner Safety Consultants’ Annual Standards Trend Reports can save you time and money by: Reducing the amount of time needed to put your list of Current Standards together for your Quality System Having an early warning system in place to be able to strategically plan your product development (in some cases you may need to redesign & […]

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 ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 +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

Why Using Proper Standards for Your Regulatory Submission is So Important – Podcast

Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a really interesting & dynamic conversation that we are sharing as a podcast with you on the use of the proper standards for your medical device regulatory submissions and why it is so important. We have teamed […]

FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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 […]

CAN/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of Recognized Standards

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 […]