ISO – Page 2 – Eisner Safety Consultants

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 📣📣

👉 ISO TC 210 WG2 met in Tokyo, Japan 🇯🇵 on 4 – 5 March 2025. 👉 WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: 👉 Add reference

10x Humanizing MedTech: Breaking The Mould For Conferences

Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA What’s 10x 2025 about you ask? Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose

MedTech Leading Voice 100 2025 Yearbook – Great Resource Tool!!

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 … It’s a guide to 100 individuals worth following

The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

Leo Eisner, The60601Guy will be visiting London 🇬🇧🎡🏰 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, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!