Regulatory & Safety Experts for Global Medical Device Approvals
๐ ISO TC 210 WG2 met in Tokyo, Japan ๐ฏ๐ต on 4 โ 5 March 2025. ๐ WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: ๐ Add reference
This is an amazing resource that MedTech Leading Voice has put together and is free to download. ‘This isn’t a “best of” list – it’s a guide to people worth following … ย Itโs a guide to 100 individuals worth following
Leo Eisner, The60601Guy will be visiting London ๐ฌ๐ง๐ก๐ฐ in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.
Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, ๐ฏ๐ผ๐ผ๐ธ ๐ป๐ผ๐ ๐ผ๐ป ๐บ๐ ๐๐ฝ๐ฒ๐ฐ๐ถ๐ฎ๐น ๐ฐ๐ฎ๐น๐ฒ๐ป๐ฑ๐ฎ๐ฟ for ๐บ๐ ๐๐ผ๐ป๐ฑ๐ผ๐ป ๐๐ถ๐๐ถ๐. Iโd love to chat!
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
We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.
Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area his focus is on EU MDR, Swiss MedDO and UK MDR.
Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical support, and the U.S.
Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan and more.
We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.