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
BSI White Paper on Human Factors & Usability
Blog focus BSI’s 7th in a series of White Papers for Medical Device, on Human Factors & Usability Engineering White Paper on The growing role of human factors and usability engineering for medical devices This white paper is on “The growing role
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
BSI White Paper on Generating Clinical Evaluation Reports
Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports White Paper on Generating clinical evaluation reports This white paper is on “Generating clinical evaluation reports – A guide
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