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Eisner Safety Consultants: Qmed Qualified Supplier
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FDA Draft Guidance – Human Factors & Usability Engineering

The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011.  A 90 day comment period is open and comments to be considered should be sent to FDA by September 19, 2011 [...]

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Two Conf’s on 60601 Series of Stds Mar 3 & 4th

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

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Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.

  Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry Usability and Human Factors verification, validation, and regulatory [...]

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Eisner Safety Consultants Newsletter #6 Now Online

Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/

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ANSI/AAMI HE75:2009 — Human f…

ANSI/AAMI HE75:2009 — Human factors engineering – Design of medical devices http://ow.ly/1hMzF