As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2
InCompliance Annual Guide Articles
The Future of the IEC 60601 Series: An Update
Read the article I wrote for InCompliance Magazine recently. I just got back from China at the end of Oct 2019 where I was at IEC meetings for 2 weeks working on IEC 60601-1, edition 3.2 and it’s collaterals and
Staying up Medical Electrical Standards – Easy, Come to MD&M West
Leo Eisner, the “IEC 60601 Guy”, will be presenting a session at MD&M West on Wednesday, Feb. 6, 2019 from 3:15 – 5:30PM Topic: Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances Track: MD&M West: Regulatory & Quality
Webinar – Standards, Standards, Standards – Makes the Medical Device World go Around
Standards are a key priority for the International Medical Device Regulators Forum (IMDRF). Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential
Standards & Regulatory Update – Medical Electrical Devices – Article
In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO)