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 today’s digital age, the question isn’t whether you’ll experience a cybersecurity attack, but when this might occur. Cybercriminals strike when you least expect it, with devastating consequences for your day-to-day operations.
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.
After the devastating fire of 2019, Notre Dame Cathedral was rebuilt and restored with the aid of digital twins.
Digital twins have become indispensable tools across industries.
Growing up in rural Pennsylvania, I didn’t have scientists for role models. In fact, I’m the first woman in my family to get a college degree, much less become a scientist.
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