The agentic workspace for quality and regulatory work.

Agents plan, execute, cite. You sign. Every step logged, every claim sourced, every signature verifiable.

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Pre-launch · Now accepting design-partner applications

Built for

Medical device companies

Live agent runCAPA · Complaint · MDR

A real Deminn run: plan, execute, cite. The agent stops at sign - you approve.

0Published skills

0Callable tools

0Indexed FDA citations

21 CFR Part 11 e-signaturesLiving FDA citation corpusCitation + quote validatorsTenant-isolatedImmutable audit trail

The problem

The work that decides the call happens off-system. In every regulated workflow.

Investigate a CAPA. Make a reportability decision. Disposition a non-conformance. Assess a change. Build a 510(k) traceability matrix. The shape is identical: pull joined evidence from systems that do not talk, make a defensible call against a clock, write the rationale in Word.

Your QMS routes the record. It does not help you make the call.

See the pain across all six workflows →What this looks like in dollars →

Evidence Matrix · Demo 510(k)

From one record to the whole submission.

The agent fills every cell with a citation. One signature binds the matrix.

Indications for use

Device description

Performance testing

Biocompatibility

Sterilization

Software documentation

0/36 cells cited

15 requirements. 84 cells. Every claim sourced. One signature. Open a sample matrix →

The Brain

One Brain. What the agent reasons against.

Every device, supplier, risk, CAPA, complaint, regulation, and SOP - one workspace, one view. Every claim provenance-linked back to a controlled source.

Devices6

+6 this week

Regulations7

+7 this week

Risk4

+4 this week

Complaints9

+9 this week

CAPA1

+1 this week

FDA & Agency3

+3 this week

SOPs4

+4 this week

Suppliers2

+2 this week

Training3

+3 this week

Audit Simulator

15,177 FDA findings. Every record red-teamed before the gate opens.

Before any record can close, Deminn red-teams it against a living corpus of FDA findings. Five weighted sub-scores. Below threshold, the gate stays closed - with the specific weakness, the FDA pattern that would catch it, and the clause-cited fix.

deminn.ai / capa / 0061 / audit-simulator

CAPA-0061

2 likely FDA findings flagged before closure

Gate closed

Finding 1
Effectiveness plan does not reference recurrence detection.
CitedWarning Letter CDRH 2024-0083
Finding 2
Root cause cites operator error without process evidence.
CitedWarning Letter CDRH 2024-0125

Audit risk score67/100

Threshold to close: 75/100

Weakness
No measurable success criterion. Plan reads "monitor production" without thresholds.
FDA pattern
~40% of CAPAs cited in CDRH warning letters in 2024 were closed without quantified effectiveness criteria. Inspectors flag this on review of the closure record itself.
What would close this
Define the criterion as a quantitative threshold (for example, defect rate ≤ 0.5%) measured at 30 / 60 / 90 days. Tie pass/fail to a documented re-open trigger.

0Indexed citations

0Sub-score gates

0Closure threshold (out of 100)

See the regulations Deminn cites →

Agent surface

Your other agents call Deminn through MCP.

Claude Desktop, Copilot Studio, LangChain, Bedrock. Every answer signed with a content hash and a verifiable source chain.

POST /api/mcp/sdk · Bearer $DEMINN_TOKENSee how it works →

Skills the Brain powers, on one agent loop.

Capabilities

83 published skills across 13 categories - all on the same agent loop, the same evidence ledger, the same Audit Simulator gate, and the same Part 11 e-signature flow. Every category is also callable through the agent surface by Claude, Copilot, or your own AI stack.

Foundational
21
The reusable primitives every workflow stands on.
- Search 21 CFR 820, ISO 13485, EU MDR, ISO 14971 in one query
- Red-team any record against a living corpus of FDA findings
CAPA & investigations
13
The entire CAPA lifecycle - triage, root cause, action plans, effectiveness, closure.
- Triage and draft a CAPA from intake to closure with cited 21 CFR 820 alignment
- Author root-cause analysis with auto-linked NCRs and supplier history
Complaints & MDR
2
Post-market events triaged with the regulatory clock running.
- Triage a complaint and draft the response
- Decide MDR reportability with cited Part 803 clauses and the 30-day deadline
NCR, change, risk, gap, SOP
5
Traditional QMS record types beyond CAPA - all on the same engine.
- NCR disposition with auto-link to CAPA and supplier feedback
- Change order with PCCP-aware impact analysis for AI-enabled devices
Document control & training
5
Author, route, train. Procedures with the regulatory references already cited.
- Draft an SOP from controlled templates with regulatory references pre-cited
- Route a procedure for review with reviewer + approver assignments resolved
Supplier quality
2
Composite scoring from history, quarterly packets, watchlist for the bottom of the curve.
- Aggregate audit findings into Quality / Delivery / Risk grades + a 0-100 composite score
- Quarterly cross-supplier scorecard with watchlist for composite below 75
Internal audit
2
Annual program planning against 21 CFR 820. Findings escalate to CAPA automatically.
- Annual audit program covering 13 QMS sub-systems mapped to 21 CFR 820
- Bridge a critical or major finding to a CAPA with bidirectional link
Management review
3
ISO 13485 §5.6.2 packets and the quality health score that explains them.
- Quarterly KPI snapshot - open-CAPA aging, complaints, MDRs, NCR rate, supplier health
- Full ISO 13485 §5.6.2 review packet with weighted quality health score
Regulatory submissions
8
US, EU, and international submissions with cited regs and Part 11 e-signatures on submit.
- 510(k) with 12-section scaffold and substantial-equivalence table for predicate vs. subject
- De Novo with 9-section scaffold and a 120-day target
Post-market surveillance
9
Signal in, escalation out. PMS plans, PSUR, PMCF, with the EU MDR clauses cited.
- PMS plan with cadence, KPI thresholds, and data-source list
- Per-1000-unit signal detection that escalates straight into a CAPA
Living regulatory intelligence
5
Match new FDA guidance, recalls, and warning letters to your portfolio. Cascade the impact.
- Match new FDA guidance / standards / recalls against your device portfolio
- Cascade impact to SOPs that cite the affected standard
External audit response
5
FDA / Notified Body / MDSAP responses with response-type-aware deadlines and tracked commitments.
- Draft an audit response with a 7-section scaffold and the right deadline for the finding type
- Compile an evidence pack from linked CAPAs and internal audit history
AI / SaMD post-market
3
The first post-market quality OS for AI-enabled devices. PCCP-aware throughout.
- Drift tracking and PCCP drafting for AI-enabled devices
- AI-aware MDR / NCR / CAPA subtypes with model-specific failure-mode taxonomy

Why Deminn

QMS is the filing cabinet. Deminn is where the work happens.

Deminn ingests records from where they already live - your QMS, a folder, or your inbox.

Works alongside your QMS, or independently. Bring Veeva, MasterControl, Greenlight Guru - or none of them.
Direct ingest, no connector required. Drop documents, forward email, paste an export.
Your records stay portable. Standard-format exports. Compounding graph. Nothing locked in.

Try Deminn on a record you actually own.

No procurement. No sales motion. Tell us what your team would test first.

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