Eisner Safety Consultants: Qmed Qualified Supplier

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 ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 +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

ESC New Annual Standard Reports Available by Early April ’16

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 Equipment Standards, Technical Reports, etc? Do you have the resources to do this efficiently and with minimal cost & time? Are you able to have one or more […]

FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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

Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants

Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]