This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS). It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC. IEC website
OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1)
This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process. There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized
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
Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices
Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions
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