What’s NASA & Star Trek have to do with IEC 60601?

What’s NASA & Star Trek have to do with IEC 60601?

From NASA to IEC 60601 – A Lifelong Trek for Safer Devices.

When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.

All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The ⭕️ Podcast, it felt like a perfect chance to bring all these threads together. Star Trek. NASA. Standards. Innovation. Human factors. EMS & Home use environments.. And above all, patient safety.

From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast

From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast

From engineer to “The IEC 60601 Guy” — my story and practical tips
I joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.

A quick personal note
Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.

Major changes to IEC 60601-1 are closer than you think

Impact of IEC 60601-1, 4th Ed.

Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

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

🎩 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.

10x Humanizing MedTech: Breaking The Mould For Conferences

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