Qevatrix Intelligence — for medical device professionals and manufacturers
AI does the drafting. People still decide.
Regulated work is mostly writing, cross-referencing and checking. Qevatrix Intelligence takes that load — and stops precisely where accountability begins.
What it does
Where Intelligence earns its keep
Drafting with provenance
Investigations, rationales, summaries and dossier sections are drafted from records already in your tenant, with every claim traceable to the source record it came from.
Cross-record consistency
Intelligence compares design outputs, risk files, labeling and submissions, and flags where they disagree before an auditor finds the gap.
Signal detection
Complaint, nonconformance and post-market data are trended continuously so recurring patterns surface as candidate signals rather than year-end surprises.
Literature and evidence synthesis
Search, appraise and summarise literature into structured evidence tables with full citation chains suitable for clinical evaluation.
Regulatory monitoring
Standards, guidance and regulation changes are monitored and routed to the product families and records they actually affect.
Reviewable output
Every generated artefact enters the system as a draft with an AI-authored marker, the prompt context and the model used, so the review record is complete.
Governance
The lines we do not cross
These constraints are enforced by the platform, not by policy documents.
- AI never approves, signs, releases or closes a regulated record.
- AI never makes a final reportability, safety or clinical determination.
- Every AI-generated artefact is marked as such and retained in the audit trail.
- Your tenant data is not used to train foundation models.
- A qualified human reviewer is always identified before an AI draft becomes effective.
See Intelligence draft a real investigation.
Bring an anonymised complaint or nonconformance and we will run it live.