Eisner Safety Consultants: Qmed Qualified Supplier
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Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants






Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]

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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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.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 […]