The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...
The "Computer System Validation (CSV) Training Course (Jan 27th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in computer ...
"Risk should be the compass, not the paperwork," said Sindhuri Korrapati, a senior software quality supervisor. It's a striking statement in a field long defined by binders, screenshots, and scripted ...
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...
The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
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