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

‘Who designed this convoluted process? A monkey could have done a better job.”

Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.

Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them.

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.

In today’s highly competitive business environment, a trusted supply chain that functions seamlessly is essential. Even small errors can affect the entire supply chain, resulting in lost revenue, unsatisfied customers, and irreparable damage to your brand.

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

Have you ever had one of those career moments where you felt like you’d made it? A moment of proof that you’d finally earned a spot at the cool or important table?