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 ...
AI-enhanced vision systems automate medical device quality control, replacing manual inspection with flexible solutions.
In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...
Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...
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 ...
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 ...
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 ...
ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it ...
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 ...
Developing test systems for R&D through production requires a combination of preparedness and ongoing evaluation. In order to carry out these tasks, the required systems must be capable of performing ...
SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results