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Ultimately, quality in an AI-driven world is determined by the design of the governance surrounding the tool, not just the capability of the tool itself.

The approach to both basketball and quality manufacturing deals with system predictability, elimination of waste, process control and enforcement, and continuous improvement.

February 2, 2026, marked the end of an era for the U.S. medical device industry.

Quality control programs in injection molding are often focused on monitoring production – measuring dimensions, tracking variation, and verifying consistency across runs. 

The FDA’s new Quality Management System Regulation (QMSR) represents the most significant shift in FDA quality system compliance in over 25 years.

Quality teams now rely on a dense stack of tools: automated test frameworks, AI assisted test generation, self healing locators, visual testing, static analysis, and observability platforms. 

Priyank Patel is a quality expert in the med-tech space, focusing on surgical robots. He's a senior member of ASQ with ASQ certification.

From a regulatory standpoint, progress in medical device development is measured by evidence, not by phase completion.

Medical device manufacturers are changing how they inspect devices, manage suppliers, and evaluate performance over a product’s lifecycle.

In medical device manufacturing, the difference between life-saving success and catastrophic failure is often measured in nanometers.