Regulatory & Safety Experts for Global Medical Device Approvals
Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for
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
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
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
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