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.
Your IT team enabled Copilot and Gemini last quarter without checking with the lawyers. Now your employees are putting company secrets into systems that nobody owns, nobody governs, and nobody can reliably retrieve when opposing counsel sends a subpoena.
The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee.
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.
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.
© 2026 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.