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Eisner Safety Consultants: Qmed Qualified Supplier
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When will FDA Issue Guidance Document on AAMI ES 60601-1, 3rd ed. + Amendment 1?

That’s a really good question and the answer is sooner than I would have thought.  Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to know if this time it will truly happen or not.  I would hazard to guess [...]

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2013 RAPS Regulatory Conf. Presentation – IEC60601-1 3rd ed., Managing Human Factors & Usability Risks

Join us at the 2013 RAPS Regulatory Convergence Conference (Boston) in the Medical Device Track on IEC 60601-1 Third edition: Managing Human Factors and Usability Risks.  Your experts that will help you through these issues are Leo Eisner of Eisner Safety Consultants, and Mark Leimbeck and Michael Wicklund of UL LLC and will be presenting [...]

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FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032

The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - Recognition List #: 031, Recognition # 5-77] has had it’s transition date moved from June 30, 2013 to [...]

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Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available

We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.  

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Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance

Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for [...]