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
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,
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!
Free presentation in London ๐ฌ๐ง๐ก๐ฐ โ With Leo Eisner, The60601Guy, & Ian Sealey
๐ช๐ต๐ฎ๐โ๐ ๐ผ๐ป ๐๐ต๐ฒ ๐บ๐ฒ๐ป๐๐ฐ?
โข Some ๐ณ๐๐๐๐ฟ๐ฒ ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ of IEC60601-1 , 4th being considered you ๐ข๐๐ฎ ๐ฃ๐ค๐ฉ ๐๐ญ๐ฅ๐๐๐ฉ:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….
โข IEC60601-1 , 4th Ed.
โข Applicable Standards
โข Future Proofing Test Plans