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Manufacturer building a new dossier
Seeking a clear structure before submission work begins.
TECHNICAL FILE · GAP REVIEW
Medical Device Technical File Review and Gap Assessment
We review the dossier as a connected evidence chain rather than a document collection, then convert observations into a prioritized and closure-ready gap register.
A service built around the client’s actual starting point
Team with an existing file
Needing an independent review of gaps, contradictions, and missing evidence.
Device with design or manufacturing changes
Assessing the impact on documentation, risks, verification, and validation.
What does the review and support cover?
- Review device description, intended purpose, classification, and variants.
- Test alignment across risk management, requirements, verification, and validation.
- Review the organization of clinical evidence, labeling, and instructions where applicable.
- Produce a gap register that distinguishes missing, insufficient, and inconsistent evidence.
A practical pathway that connects the regulatory decision to evidence and documentation before submission.
Fix the baseline
Identify the device, versions, variants, markets, and documents representing the current state.
Check the structure
Verify dossier sections are complete, searchable, and connected.
Test the evidence
Trace claims, requirements, and risks to verifiable reports and results.
Close the gaps
Prioritize observations and define owners, actions, and acceptance evidence.
Direct answers before engagement
Does a review include writing the complete dossier?
Not necessarily. The scope may be an independent review, review plus closure support, or preparation of defined sections after responsibilities are agreed.
Is a document index enough?
An index helps organization but does not demonstrate evidence sufficiency, traceability, or consistency across dossier sections.
What is the main output?
Typically, a structured gap register describing the observation, available evidence, impact, priority, owner, required action, and closure criteria.
References used for this content
These links are reference points. The latest version and case-specific requirements should be verified before a regulatory decision is made.
DIRECT CONTACT
Start with a clear assessment before submission
Share the device, target market, and current dossier status. We collect only the information needed to respond to your request.