AI Governance
Source-linked regulatory drafting: what validation should mean
Citations are necessary, but reliable regulatory drafting also requires scope, context, review, and controlled approval.
A citation can show where language originated, but it does not prove that the conclusion is correct for a specific product. Validation must address retrieval, interpretation, context, and human review.
Preserve the source record
Maintain authority, title, version, date, jurisdiction, applicability, retrieved passage, and access history. A URL alone is not an adequate regulatory record.
Test the conclusion
Review whether the source supports the statement, whether exceptions apply, whether more current information supersedes it, and whether product-specific facts change the interpretation.
Traceability makes a conclusion reviewable. Qualified review makes it usable.
Control the output
Drafts should carry status, author or system attribution, reviewers, version history, source links, and approval state.
Further regulatory context
Read medical device regulatory definitions and authoritative references. Explore the workflows eeRegOS supports.
Editorial note: This content is educational and does not constitute legal or regulatory advice. Product-specific decisions should be reviewed by qualified professionals using current authoritative sources.