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Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources. Check out our updates in this LinkedIn Article. Updates are all underlined: Mar 7, ’17 updates: * addition of the EU
Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR
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
BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.
This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations 9 April 2014 – Today marks the beginning of a series of white papers that BSI has