Medical

RSS

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. 

In February 2024, the FDA took a bold step that will change the regulatory landscape of the medical devices industry as we know it.

When people think of medical devices, they often picture pacemakers, insulin pumps, or MRI scanners. Increasingly, however, medical innovation no longer comes in metal or plastic—it comes in code. Software as a Medical Device (SaMD) refers to software intended to perform a medical function without being part of a physical device.