Eisner Safety Consultants: Qmed Qualified Supplier
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Standards Reconnaissance Subscription Service Coming Soon

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for […]

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FDA Updates Guidance on Device Classes Exemptions from Premarket Notifications Requirements

This post covers 8 product codes added & updates made to the guidance on Device Classes Exemptions from Premarket Notifications Requirements On Aug 14, 2015 FDA updated the Final Guidance Document titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”.  It was originally issued as a […]

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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 […]