On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime.

Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth.

The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.

Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.

Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country.

Rigid endoscopes are used in medical diagnostics and therapy to examine body cavities and hollow organs, and to perform minimally invasive procedures. To avoid risks for patients and medical staff, it’s essential that the devices function perfectly.

The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.