Hospira, a hospital products and anesthesia drug manufacturer, received an FDA notice for the quality of its devices, according to News and Insight. After an inspection of Hospira’s medical device ...
Medical device manufacturers are adopting integrated quality management systems that extend past compliance to drive cost ...
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 ...
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...
To improve the overall safety and performance of medical devices, the United States FDA has proposed an amendment to the Code of Federal Regulations (CFR) for 21 CFR4 Part 820 of the current good ...
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Chapter 14: Current Good Manufacturing Practices and Quality System Design Chapter 15: Canadian Good Manufacturing Practices and Establishment Licensing Chapter 25: Components of a REMS: Communication ...
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 ...
SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today ...
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