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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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Tips for Success When It Comes to IEC 60601-1 – Podcast






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 IEC 60601-1. Eisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System […]

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FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices






On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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

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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 […]