FDA’s new CSA guidance: transforming software validation for production and quality systems

▤ Summary

The FDA has finalized new Computer Software Assurance guidance for software used in medical device production and quality systems. The guidance shifts validation away from exhaustive documentation and toward a risk-based approach that focuses on software functions affecting product quality, patient safety, and process integrity. It also encourages teams to use vendor documentation and SDLC artifacts as evidence instead of duplicating testing work. For software vendors and service firms, this creates demand for CSA consulting, validation support, and compliance tooling aligned with FDA, ISO 13485, and EU MDR requirements.

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