On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”. The Guidance was developed to describe the types of information that the FDA expects to be
Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants
Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed
Scrip Regulatory Affairs Article on IEC 60601-1 for US & Canada
11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1. The technical report tiled IEC TR 60601-4-3:2015
Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015
Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”. This report is available from AAMI