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
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
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
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.