Discover how medical 3D printing creates patient-specific devices and custom prosthetics. Read our guide to clinical ...

The medical billing process can be frustrating. Converting your patient notes to numbered claims can introduce human error and insurers can be strict about how claims ...

Precision molded thermoplastic parts are used in everything from catheters and IVD cartridges to drug-delivery systems. In fact, the vast majority of medical devices include precision molded ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

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 ...

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?

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...