Risk Management – Page 2 – Eisner Safety Consultants

🎥 IEC 60601-1 4th Edition: Design Controls And QMS Impacts You Need To Know 📣📣

On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.

We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.

🎩 Get your reviewer’s hat on – IEC 60601-1, 4th Edition Draft Fragments Have Dropped‼️ 🚀

Over the last two weeks – and with a Friday night (6/20/25 Geneva time – late) finale still to come – we’ve seen CD1s and CD2 (WG 47 ONLY) fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 from WG 41 through WG 48, but for WG 45.

This is not just standards spring cleaning – these are foundational changes to the IEC 60601-1 General Standard, folding the Collateral standards into the core. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes. If you’re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file… you need to review this.

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.

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