JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
RAPS

Blood Establishment Computer Systems Must be Properly Validated, FDA Guidance Says

A new final guidance document released by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) puts into place voluntary guidelines for blood establishments ...
RAPS

FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for ...
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Modernizing biotech compliance: Inside the transformation of enterprise validation systems

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...