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Eisner Safety Consultants: Qmed Qualified Supplier
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Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet?

This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it. On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards into the list of ‘Appropriate NRTL* Program Test Standards’.  With this announcement they have officially [...]

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IEC 60601 Medical Electrical Equipment Classifications: FAQ’s

IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog.  Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3rd ed or 3rd ed. with Amendment 1 [...]

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Where is EU headed with Proposed Medical Device Regulations by ENVI?

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices.  Note, this issue is not set in stone and you should read some of the [...]

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Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance

Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).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 [...]