SiMD – Eisner Safety Consultants

Keep the Patient at the Center: My Full Week at IMSC26 (and Why Getting Ahead of IEC 60601-1, 4th Edition Is Really About People)

Two events across Greater Boston, and the most energizing week I have had in MedTech in a long time. It started in Boxborough with the TÜV Rheinland North America IEC 60601-1, 4th edition seminar, then rolled into four days at IMSC26 in Boston: a 4-hour CEF/CEP workshop, a 45-minute session to a packed room plus a virtual audience, and a stack of hallway conversations I am still thinking about.
What I did not expect was how often the human side moved to the front. A patient’s own account of life on the receiving end of a device. A regulator speaking candidly about where the FDA is headed. Combination products, risk management maturity, usability, and the quiet, unglamorous work of writing the standards themselves. Different rooms, different speakers, the same gravitational pull back to the patient.
So I wrote up the moments that earned a place in my electronic notebook, what they mean for teams designing and testing products right now, and where IEC 60601-1, 4th edition fits into the picture. Less a conference summary, more a field report from someone who has spent 30-plus years in this work and still came home with a full page of new ideas.

IEC 60601, 4th Edition: What’s Changing and How to Prepare

IEC 60601-1, 4th Edition
Strategic Shifts and How to Prepare

Companion post to my Easy Medical Device podcast episode on IEC 60601-1, 4th Ed., focused on what is shifting across the Working Groups and what RA/QA, Design, Test, and Management teams should do now.

Most organizations will feel the impact long before any formal transition date. The practical shift is that evidence expectations are tightening, scope is becoming clearer, and the standard’s direction is being shaped now through Working Group outputs. Teams that treat this as a design input and planning topic today will avoid late-cycle surprises in test strategy, labeling, and documentation tomorrow.

Medical Device Compliance & Certification Summit – Why It Matters?

Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle. IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly expect standards interpretation, risk decisions, and test strategy to be visible and justified during design reviews and technical documentation development.

This shift is showing up in real ways – through tougher design reviews, deeper questions during pre-submission interactions, and increased scrutiny of how standards were applied, not just whether a final test report exists.

To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day, in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulatory expectations intersect in real programs.

This is a focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements, certification strategy, and regulator guidance documents across FDA, EU, and other markets.

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.

IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech

The 4th Edition of IEC 60601-1 is no longer a future concern. Eleven of the twelve hazard fragments (WGs 37–48) have circulated Committee Drafts (CDs). All fragments have issued first CDs (WG 47 is at CD2), except WG 45 (Optical Radiation Hazards).

That means manufacturers, design houses, trade associations, test houses, and regulators must follow the working group outputs closely. If you cannot stay directly engaged in National or International (IEC) committees, you will need trusted expert guidance. These changes will impact design, QMS, labeling and IFUs, documentation, and test strategies.

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