Rock-Solid Data Integrity & Software Assurance: CSV vs CSA, Audit Readiness, and FDA Remediation for Medical Devices

In the medical device industry, the margin for error is razor-thin. Regulatory agencies like the FDA expect manufacturers to ensure not only that their devices are safe and effective, but also that the data supporting them is trustworthy, consistent, and compliant. That’s where a rock-solid data integrity program and robust computer software assurance strategies become mission-critical.

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