Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
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 ...
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...
The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for violations of current good manufacturing practices (CGMP). Additionally, ...
The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...
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 Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
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