Glossary
Updated
The ongoing process of mapping legal requirements to technical and operational controls (privacy-by-design for GDPR, explainability and clinical validation for FDA, audit trails for financial regulators) and then implementing, monitoring, and documenting those controls. Compliance activities include legal-impact assessments, automated policy enforcers, training programs, and periodic audits to demonstrate adherence to regulatory obligations.
Example
A medical-device company ensures FDA compliance for its diagnostic-AI by conducting clinical trials, documenting software validation activities, and maintaining a design history file. Post-market, they monitor adverse events and submit regular safety reports to regulators, aligning technical practices with legal mandates.