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 ...

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?

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

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 ...

Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

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 ...

In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

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 ...