Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA’s own discussions and actions around ...
Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
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 ...
The chemical used to sterilize half of all medical devices in the United States is also known to cause cancer. After years of deliberating on alternatives, the Food and Drug Administration this month ...
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 ...
Lucknow: In a major push to strengthen India's medical device and pharmaceutical manufacturing ecosystem, the Uttar Pradesh govt is working on an ambitious project to establish a US FDA-accredited ...
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