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.
Key takeaways from the episode
On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my genesis story of how I became known as The “IEC 60601 Guy”. Duane asked me to give listeners a 101 course on the IEC 60601 series, and I explained how I strive to “de-Greek” or demystify the standard series, and gave a preview of the big shifts coming in 4th Edition.
The “big picture” structure of the general standard, collateral standards, and particular standards
How lifecycle standards (risk management, usability, software) compare to type test standards in the 60601 family
Tangible changes to watch in the upcoming 4th Edition: clearer alarm requirements and impacts on design, QMS, & documentation
Why leaning on experts (internal or external) is key to getting this right for the impacts of 4th Edition
My goal is to “de-Greek” the process and show that IEC 60601 can be a roadmap 🗺️, not a riddle
Whether you’re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a roadmap you can follow, instead of a riddle you can never quite solve.
What peers said
“If you want to know more about IEC 60601, Leo is the resource to go to … I recommend this episode to everybody working with medical electrical equipment.”
— Beat Keller“Great to see how you became such an expert … I hope your story inspires young professionals to invest in becoming experts themselves.”
— Ronald Boumans“It’s amazing that you covered the difference between process and test standards — there’s still a lot of confusion out there.”
— Tibor ZechmeisterHow We Can Help
If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.