New process device profiles have been added by ODVA to the EtherNet/IP specification to provide end users with another tool to help optimize plant operations. According to ODVA, the new process device ...

WALDWICK, N.J.--(BUSINESS WIRE)--NextPhase Medical Devices LLC, a leading provider of electronic manufacturing services (EMS) and single-use disposable devices to leading medical device OEMs, recently ...

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 ...

(MENAFN- GlobeNewsWire - Nasdaq) Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK ...

BOSTON--(BUSINESS WIRE)--908 Devices Inc., (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, announced that National Resilience, Inc.

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?

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 ...

Staying inside increasingly narrow process windows as specialty devices scale, diversify, and enter high-volume production.

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 ...