Eisner Safety Consultants: Qmed Qualified Supplier
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Global Medical Device Regulatory & Standards Updates






Enjoy our Second global standards & regulatory update.  It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of […]

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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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ISO 13485:2016 is Now Available – Start Planning Your Transition






This post will help you understand some of the steps you should start taking immediately to implement your new ISO 13485:2016 QMS. Updated with additional info on 29 February 2016 and 5 April 2016 (Update is italicized) Are you ready for the 3 year transition that just started to get your Medical Device Quality System […]

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World-Wide Medical Device Regulatory & Standards Updates






Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards […]

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FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices






On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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