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Process validation, according to the FDA’s Quality System Regulation (QSR), means “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” In other words: If a devicemaker cannot verify, by inspection or test, that each product specification has been met, the process itself must be tested, to ensure that it yields consistent results. Read More
The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More
The UK’s Department of Health and Social Care is seeking information for an independent review of the potential ethnic bias of certain medical devices such as oximeters and infrared scanners. Read More
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More
Researchers in Europe used Abbott’s i-STAT TBI (traumatic brain injury) test to show how two blood-based biomarkers can effectively predict the initial outcome of such injuries. Read More
Long-term results from the clinical study that supported the FDA’s approval of Channel Medsystems’ Cerene Cryotherapy system show that the device continued its steady reduction of heavy menstrual bleeding after three years. Read More