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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MDD Harmonized List of Standards Website Moves & Medical Device Sector Page Changes

On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location. The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived. […]

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Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds

This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS).  It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC.  IEC website states: “By purchasing this FDIS now, you will automatically receive, in addition, the final publication.”  […]

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EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News About? On 16 May 2014 the Official Journal of the European Union (OJEU) published an […]

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IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2

In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1.  We use several figures to explain these critical concepts. If you need help with the IEC 60601 series of Standards, […]