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
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
Update to BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s
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.
BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s
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
MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
7 March 2014 – MD&DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard