The Hidden Cost of Technical Debt in Medical Device Development
Engineering expertise and regulatory accountability almost never sit in the same person. As of February 2, 2026, FDA’s new inspection framework follows risk across the full product lifecycle—and that gap is no longer a background risk. It is a current exposure.
Safety-Rated PLCs: The Missing Link Between Medical Device Innovation and Regulatory Excellence
Chemical plants, oil refineries, and aerospace adopted safety-rated PLCs decades ago. Medical device manufacturers are still using safety relays. With FDA’s QMSR and mandatory IEC 62443 cybersecurity requirements now in effect, that gap is a liability—not a choice.