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.
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)
