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15 Steps to Get IEC 60601-1 Approval – Webinar






Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a Webinar on the 15 Steps to Get IEC 60601-1 Approval on December 13, 2016 1PM ET/10AM PT.  Sign-up now for the limited live seating of […]

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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 & […]

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 ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 +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

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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 […]

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FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices






On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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