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

History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success.

Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S.

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).

Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be.

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.

Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages.

Supply chain quality control is a demanding job.

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.

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.