Quality and Regulatory Affairs in Medtech
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
In modern manufacturing, the smartest factories know that safety comes first. Any injury, equipment problem, or unexpected stop can slow everything down.
The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee.
For years, manufacturers have been told the future of Industry 4.0 lives in the cloud. Vendors promised plug-and-play AI that could analyze everything, automate anything, and transform the factory floor overnight.
Performance rarely collapses with fanfare. More often, it flatlines quietly; sales soften, productivity slows, priorities blur, and yet teams run hard without moving the needle.
In manufacturing, failure isn’t an option—it’s a liability. A defective part or a missed delivery triggers a chain reaction that can disrupt schedules, undermine trust, and drain resources.
In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters.
Management by objectives isn’t just a way to set direction for an organization. It’s a prerequisite for creating sustainable development and a culture of continuous improvement.
Rockwell engineers with their Artec Leo 3D scanner.
Regular inspection is absolutely vital with industrial transmission systems. Just like the gearbox in an everyday car, components are prone to wear, misalignment, and fatigue—issues that can lead to machinery failure.
I’ve had this conversation countless times—sometimes with a frustrated client, often with a colleague, and occasionally with my own reflection.
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