On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...

Life Assure structures systems with 24/7 monitoring, which enables a rapid connection to trained professionals during ...

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

The U.S. Food and Drug Administration published a draft guidance this past week with regard to medical device cybersecurity. The draft guidance, "Cybersecurity in Medical Devices: Quality System ...

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today ...