Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines

Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions

Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.

Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays

Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting ๐Ÿ“ฃ๐Ÿ“ฃ

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting ๐Ÿ“ฃ๐Ÿ“ฃ

๐Ÿ‘‰ ISO TC 210 WG2 met in Tokyo, Japan ๐Ÿ‡ฏ๐Ÿ‡ต on 4 โ€“ 5 March 2025. ๐Ÿ‘‰ WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: ๐Ÿ‘‰ Add reference

Time and Regulators Wait for No One – Free Presentation

Time and Regulators Wait for No One – Free Presentation

Free presentation in London ๐Ÿ‡ฌ๐Ÿ‡ง๐ŸŽก๐Ÿฐ โ€” With Leo Eisner, The60601Guy, & Ian Sealey

๐—ช๐—ต๐—ฎ๐˜โ€™๐˜€ ๐—ผ๐—ป ๐˜๐—ต๐—ฒ ๐—บ๐—ฒ๐—ป๐˜‚๐Ÿฐ?

โ€ข Some ๐—ณ๐˜‚๐˜๐˜‚๐—ฟ๐—ฒ ๐—ฟ๐—ฒ๐—พ๐˜‚๐—ถ๐—ฟ๐—ฒ๐—บ๐—ฒ๐—ป๐˜๐˜€ of IEC60601-1 , 4th being considered you ๐™ข๐™–๐™ฎ ๐™ฃ๐™ค๐™ฉ ๐™š๐™ญ๐™ฅ๐™š๐™˜๐™ฉ:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….

โ€ข IEC60601-1 , 4th Ed.
โ€ข Applicable Standards
โ€ข Future Proofing Test Plans

What Standards Apply to My Device? Podcast #383

What Standards Apply to My Device? Podcast #383

๐—ช๐—ต๐—ฎ๐˜ ๐—ฆ๐˜๐—ฎ๐—ป๐—ฑ๐—ฎ๐—ฟ๐—ฑ๐˜€ ๐—”๐—ฝ๐—ฝ๐—น๐˜† ๐˜๐—ผ ๐— ๐˜† ๐——๐—ฒ๐˜ƒ๐—ถ๐—ฐ๐—ฒ? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru’s very own

๐—ž๐—ฒ๐˜† ๐—ง๐—ผ๐—ฝ๐—ถ๐—ฐ๐˜€:โ€ผ๏ธ
โ€ข Why standards like IEC60601 are crucial for medical device development
โ€ข Steps for identifying proper standards for your product
โ€ข How to integrate standards into your design process
โ€ข Mistakes & consequences of ignoring standards
โ€ข Tools for staying updated on changing standards & regulations
โ€ข How startups can navigate standards with limited resources

How to ID Applicable Standards – Combinate Podcast

How to ID Applicable Standards – Combinate Podcast

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