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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 ...

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 ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Keeping these standards in mind, this article will outline three types of wireless interfaces that can be useful in connected medical devices: Bluetooth, Wi-Fi, and ZigBee and discuss different levels ...

Certain Philips' patient monitoring products are the subject of new security alerts from the manufacturer and CISA. Federal regulators and Philips this week issued advisories pertaining to several ...

FREMONT, Calif.--(BUSINESS WIRE)--Nitinol Devices & Components, Inc. (“NDC”), announced today it has successfully completed the acquisition of Interface Catheter Solutions (“Interface”). Reflecting ...

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...