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Clinical-grade documents,
patient-grade privacy.

Clinical documentation and regulatory files drafted from your own sources, with patient data processed inside your own perimeter — never sent out, never used to train a model.

How sovereignty works
ON-PREM OR SOVEREIGN EU CLOUDZERO DATA EGRESSNEVER TRAINED ON YOUR DATA

Clinical files, reviewed together.

@mention a specialist on a report; PHI never leaves your environment.

Finalise the clinical evaluation report28 / 187
Finalise the clinical evaluation report
MDR Annex XIV — performance claims need source evidence.
Activity
K karri created the review · 5min ago
Kkarri 4 min ago
Can we cite the sensitivity claim to the study?
AAlex just now
@Researcher can you evidence the claim?
Alex connected Researcher · just now
Researcher · Working 00:20
Reading study MD-22, table 6
MDR-118
In Progress
Medium
AAlex
Researcher
LABELS
Clinical
CYCLE
Review 144
PROJECT
Regulatory Affairs

A Researcher that keeps PHI in.

It reads the studies in your environment and writes the report — every claim cited.

PHI STAYS INMDR / IVDR
ResearcherWorking
On it — opening the study set.
Reading MD-22 and the PMS data
Sensitivity 94% vs the reference
Drafting the evaluation, cited…
Reading 6 studies…
Delegate to…
ResearcherAgent
Legal AnalystAgent
Data AnalystAgent
WriterAgent
S Steven
M Meg

PHI never leaves your walls.

Diana runs inside your environment, so patient data is processed where it lives — never sent to a public model, never used for training.

ON-PREMPHI STAYS INZERO EGRESSEU ONLY

Every statement cites the study.

Built to be evidenced for MDR and IVDR: each claim links back to the study, report or record it rests on — ready for audit.

Liability is capped at 12 months’ fees.§ 11.2
Termination for convenience on 90 days’ notice.§ 9.1
DPA omits an EU SCC module for transfers.DPA § 4
Auto-renewal runs 24 months.§ 3.3

A clinical evaluation, fully evidenced.

Diana drafts the report from your studies and post-market data, with every performance claim pinned to the evidence.

Document
clinical-evaluation-report.docx Editable Download
CLINICAL EVAL
Clinical Evaluation Report
Regulatory Affairs · MDR Annex XIV
Clinical background

The device addresses early detection in a population of 1,200 patients.

Study · MD-22, p.14
Performance

Sensitivity of 94% was demonstrated against the reference standard.

Study · table 6
Conclusion

The benefit-risk profile supports the intended purpose.

PMS · 2026 report
Ask Diana about this document — select a line to cite or redline…

Evidenced and confidential.

Work on the file

Open a clinical report and ask Diana to summarise, check or draft in context.

Audit-ready

Every action logged inside your perimeter.

Submissions as Skills

Recurring regulatory documents become repeatable workflows.

The work you hand to Diana.

Draft a clinical evaluation reportPDF
Compile a technical fileDOCX
Prepare a regulatory submissionPDF
Summarise a study into findingsXLSX

What the team asks.

Does PHI ever leave our systems?
No — patient data is processed in place and never used for training.
Is every claim traceable for MDR/IVDR?
Yes — each statement links to the study, report or record behind it.
Can recurring submissions be standardised?
Yes — turn them into repeatable Skills your team runs on demand.
How does Diana get our documents?
You attach files or point it at a project folder — nothing is uploaded to a third party. It reads them in place, inside your environment.
How do we get started?
Request a deployment and we install Diana on your own infrastructure or a sovereign EU cloud, with your templates and sources connected.

What you’ll produce.

Inside your environment.

DRAFTS
Clinical_Eval_Report.pdfPDF
Technical_File.docxDOCX
Regulatory_Submission.pdfPDF
Study_Summary.xlsxXLSX
Runs on your infrastructure. Zero data egress. Never used to train a model.

Sovereign AI,
on your terms.

Give Healthcare & MedTech a workspace that turns your own sources into finished work — entirely inside your walls.

See the architecture