medicaldeviceslegal.com comes through again with another fantastic post of 7 Dec 2013 by Erik Vollebregt of Axon Lawyers that is full of valuable information and is a good summary of where things stand and what is expected to happen when
OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards
OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!! News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test
Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
Presentation on EU RoHS2 and Its Impact on the Medical Device Industry
Leo Eisner will be presenting on the topic “RoHS2 and Its Impact on the Medical Device Industry” at an FX Conferences event on 17 Dec, 2013 (Tues) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
IEC 60601 Medical Electrical Equipment Classifications: FAQ’s
IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as