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Eisner Safety Consultants: Qmed Qualified Supplier
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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 [...]

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Part 2 – Wearables the rage but are they medical devices?






Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more From the previous “Wearables the rage but are they medical devices?” blog post I indicated that to determine if Wearables are medical devices you must a) review the definition of [...]

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510(k) Workshop at 10X Conference






On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission Valley.  It would be great to meet you at this workshop or the entire conference [...]