Regulatory & Safety Experts for Global Medical Device Approvals
Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,
in a conversation with Subhi Saadeh of Combinate Podcast
as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148
Standards: Explosion and Challenges Maintaining/Updating
My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.
The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.
In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not