Eisner Safety Consultants: Qmed Qualified Supplier
Print This Post Print This Post

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 […]

Print This Post Print This Post

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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.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

Print This Post Print This Post

NBRG Risk Mgmt Draft Consensus Paper on Interpretation & Application of Annexes Z in EN ISO 14971:2012

Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that […]

Print This Post Print This Post

Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices

Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices   This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices. On 18 June 2014 Eucomed released a Press Release about a document […]

Print This Post Print This Post

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 […]