Management

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With February 2026 now behind us, the FDA’s Quality Management System Regulation (QMSR) is here. For medical device manufacturers, the question has shifted from “are we ready?” to “can we demonstrate it?”

Certification preparation shifts that vantage point. It demands conceptualization and integration across the full system, including domains you’ve never been required to use professionally.

The next evolution of quality management will depend less on collecting additional information and more on connecting information that already exists.

Jon Reneberg is the lead digital manufacturing specialist at Purdue Manufacturing Extension Partnership, or MEP.

In this interview, Karnik discusses the technical and organizational challenges of semiconductor NPI, how yield ramp exposes hidden manufacturing risks, and what it takes to move emerging technologies into high-volume manufacturing with confidence.

After decades beside injection molding machines, I have learned an important truth: Data can provide facts, but only human intuition can reveal the truth behind them.

In production AM, the question that matters is not only “Do you have a procedure?” It’s also “Can you prove what actually happened to this part, quickly, consistently, and at scale?”

Quality leaders now face a new challenge: how to reengineer quality systems for an increasingly intelligent and connected world.

Many suppliers are primarily motivated by purchase orders. While they may enjoy being “wined and dined,” what suppliers really prefer from their customers as reward for superior performance is additional business.

The collaboration between Amro Fabrication and Verisurf Software demonstrates how precision manufacturing and digital inspection can enable missions once thought impossible.