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

Global Medical Device Regulatory & Standards Updates






Enjoy our Second global standards & regulatory update.  It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of […]

Print This Post Print This Post

World-Wide Medical Device Regulatory & Standards Updates






Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards […]

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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.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