Eisner Safety Consultants: Qmed Qualified Supplier

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 […]

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 […]

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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.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

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 […]

Status Update on NBRG Risk Management Consensus Document

This post is a status update on the NBRG RMWG Risk Management Consensus Document 30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because […]