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
IEC 60601-1-12 Just Published – MEE & MES Intended for Use in Emergency Medical Services Environment
This is a newly released standard as of 19 June 2014. Are you ready to use this standard for your emergency medical services equipment (i.e. equipment used in and around ambulances and at locations where emergency medical services would be
Several Test Labs Awaiting Approval for AAMI ES 60601-1, ed. 3.1 under OSHA NRTL Program
Several NRTLs, who are currently recognized for UL 60601-1, have applied to OSHA to add ANSI AAMI ES60601 + Amendment 1 to their scope of recognition. OSHA is currently reviewing these applications and anticipates the final recognition for these NRTLs
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