Who is this service for?
- Manufacturers building a new dossier
- Teams seeking an independent review of an existing file
- Products needing change-impact review across evidence
TECHNICAL FILE · GAP REVIEW
Technical File Review and Evidence Gap Assessment
We test the dossier from device definition through supporting evidence and distinguish missing documents, insufficient evidence, and cross-section inconsistency.
What the review needs
- Device description and variants
- Dossier index and documents
- Risk management and verification reports
- Labelling and instructions for use
Reviewable deliverables
Dossier map
Fix the device baseline
Prioritized gap register
Check structural completeness
Traceability matrix
Trace claims and risks to evidence
Finding-closure criteria
Deliver an actionable closure register
Technical documentation and product compliance
Read the work caseRebuilding evidence traceability for a generic therapeutic-device dossier
A work case on connecting risks, design requirements, verification, and labelling in a therapeutic-device dossier.
Before engagement
Is a table of contents sufficient?
No. Organization does not prove evidence sufficiency, consistency, or traceability.
Does review include writing every document?
That is agreed separately after review; the default scope is assessment and gap definition.
Official references
Sources describe the general framework. Current versions and case-specific requirements must be checked before a regulatory or commercial decision.
NEXT STEP
Request a dossier-readiness review
Sources describe the general framework. Current versions and case-specific requirements must be checked before a regulatory or commercial decision.