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AI-Powered Compliance & Gap Detection

An intelligence layer
across hundreds
of documents.

Confideck's AI layer understands semantic relationships between documents — not just keywords. It identifies missing content, contradictions between documents, and compliance gaps across the entire technical file, continuously and before submission.

Regulatory Affairs PRRC Pre-Submission Review MDR / IVDR
0

Known gaps entering a Notified Body review

How it works

Not keyword matching.
Semantic understanding.

01
Semantic document model built
Confideck's AI maps the meaning and regulatory intent of every content element — not just what is written, but what it covers, what it implies, and what it is required to address.
Semantic layer
02
Cross-document relationships analysed
The AI identifies how documents relate to each other in regulatory context — risk management linked to clinical evaluation, intended use aligned with labelling, GSPR coverage verified across the file.
Relationship mapping
03
Gaps and inconsistencies surfaced
Missing content, contradictory statements, and incomplete regulatory coverage are flagged in context — with the specific location, the expected requirement, and the nature of the gap shown clearly.
Gap detection
04
Pre-submission check run
Before a submission package is assembled, a comprehensive compliance check is run across the entire technical file — giving the team a structured list of issues to resolve before the Notified Body sees anything.
Pre-submission gate

The outcome

Compliance issues found
before they become findings.

0
Known gaps entering NB review
Every identifiable gap is surfaced and resolved before the submission package leaves the team — not discovered during assessment.
↓
Fewer NB findings and rework cycles
Semantic analysis catches contradictions and coverage gaps that manual review and keyword search routinely miss.
100%
Of the technical file checked, not just the submission
Compliance monitoring runs continuously across the entire documentation environment — not only triggered at submission time.