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Back by Popular Demand – Wearable Medical Devices – FDA’s Current Thinking






As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry.  Leo Eisner will be speaking on Medical Device Wearables & FDA’s Current Thinking with respect to a slew of [...]

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Presentation on Wearable Medical Devices – Current Thinking from FDA






Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern).  The best thing is you don’t [...]

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Scrip Regulatory Affairs Article on IEC 60601-1 for US & Canada






11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1″ Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada. [...]

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IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published






IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1. The technical report tiled IEC TR 60601-4-3:2015 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3rd ed of IEC [...]

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Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015






Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed [...]