Medical device regulatory intelligence
Regulatory intelligence is more than collecting news. It is a controlled process for finding authoritative changes, deciding whether they affect the company, and recording what must happen next.
Start with controlled sources
Define which authorities, legislation databases, guidance libraries and standards notices matter for each marketed or planned product. Record the original URL, publication date and retrieval date so every assessment can be reconstructed.
Separate signal from applicability
A newly published document is not automatically a product change. Screen its jurisdiction, device scope, effective date, transition provisions and relationship to the product’s intended purpose and lifecycle.
- Confirm the source is official and current
- Identify the affected market and device category
- Record an applicable, potentially applicable or not-applicable conclusion
- Assign a human reviewer for consequential decisions
Translate conclusions into ownership
For applicable changes, identify the affected product records, QMS processes and evidence. Create actions with an owner, due date, deliverable and completion evidence rather than closing the review with a narrative summary alone.