UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014. We have a great line up that day
IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2
In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1. We use several figures to
Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1
A Q&A post based on questions in the 25 Nov ‘13 post on OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards
IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2
This blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard. This blog discusses the following points: Definition of APPLIED PART Examples of APPLIED PARTS for specific medical devices Examples of different
EU Council Meets Tues 10 Dec Proposals for Med Dvc & IVD Regulations
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