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FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices






On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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

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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 […]

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AS/NZS IEC 60601.1:2015 (Edition 3.1) Just Published






Just Published on 23 Sept 2015 the Australian / New Zealand Joint Standard AS/NZS IEC 60601.1:2015 which is based on the complete IEC 60601-1, edition 3.1:2012 (identical).  The only differences are in the AS/NZS IEC 60601-1:2015 the preface states to a) replace the international standards references with references to Australian or Australian / New Zealand Standards, b) replace in the source […]