At the corner of quality and assembly, design engineers are frequently confronted with unexpected, complex fluid process issues in the prototyping phase.

The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed.

Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden.

When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality.

Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms.

At Ramirez & Co., a midsize business with decades of wins, leadership thought its biggest challenges were competitors, technology, and the market. Close, but no cigar.

What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam.

Take two aspirin and call me in the morning: If only prescribing medications were as simple as that.

A few years ago, I heard on the news that many people were being hospitalized with a condition of excess fluid in the lungs, called pulmonary edema.