Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

At some point, imperfections are likely to creep into every kind of manufactured product. But in the world of medical devices, there’s no margin of error. Does it ...

When it comes to medical device design—a broad category that includes a range of different machines performing countless critical functions—the stakes are high. Because no matter the application, ...

The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...

Demand for medical ICs used inside and outside the body is growing rapidly, but unique manufacturing and functional requirements coupled with low volumes have turned this into a complex and extremely ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...