Regulatory grounding
Every claim points to a real FDA citation.
The Audit Simulator scores every record against a living corpus of FDA recalls, enforcement reports, MAUDE narratives, and CDRH warning letters. Drafts cite specific sub-clauses - because that is what inspectors expect.
What’s in the corpus
Four public FDA sources, refreshed on a cadence. Each row links back to the specific clauses inspectors cite.
FDA recalls
openFDA recall enforcement feed
Class I, II, and III recalls with firm response, root-cause classification, and citing CFR clauses.
Enforcement reports
FDA enforcement-action records
Enforcement actions tied to medical-device firms with the action, cited regulation, and resolution status.
MAUDE device events
Manufacturer And User Facility Device Experience
Adverse-event narratives with product codes and reporter classifications - the field-data layer.
Warning letters & 483s
CDRH inspection outputs
Warning letters and 483 observations parsed to link each finding to a specific 21 CFR sub-clause.
The regulations Deminn cites
Six regulations, indexed at the sub-clause level.
21 CFR Part 820FDAQuality System Regulation
The US QMS for medical devices. Design controls, CAPA, production, complaints, management responsibility.
Sub-clauses indexed§820.30Design controls§820.100Corrective and preventive action§820.198Complaint files§820.50Purchasing controls
What inspectors look forGeneric Part 820 citations without the specific sub-clause are routinely flagged.
How Deminn cites itDrafts cite the specific sub-clause (e.g. §820.100(a)(3)) with the verbatim clause text.
21 CFR Part 803FDAMedical Device Reporting
The MDR rule. Which adverse events must be reported, what the report contains, and when it must be filed.
Sub-clauses indexed§803.20How to report§803.50Reportable events for manufacturers§803.53Five-day reports§803.56Supplemental reports
What inspectors look forLate submissions and missing reportability rationale are the two most common Part 803 findings.
How Deminn cites itDecisions cite the triggering clause and stamp the 30-day clock from the date of awareness.
21 CFR Part 11FDAElectronic records, electronic signatures
How electronic records and signatures count as the regulatory equivalent of paper.
Sub-clauses indexed§11.10Controls for closed systems§11.50Signature manifestations§11.70Signature / record linking§11.200Electronic signature components
What inspectors look forInspectors test the link between record, signer, timestamp, and the audit trail behind them.
How Deminn cites itClosure signatures require password reverify; audit trail is append-only with SHA-256 chain hashing.
21 CFR Part 812FDAInvestigational Device Exemption
The IDE rule. Covers significant-risk and non-significant-risk studies, sponsor duties, and records.
Sub-clauses indexed§812.20Application§812.46Monitoring investigations§812.140Records§812.150Reports
What inspectors look forSponsor monitoring lapses and protocol deviations are the most-cited IDE findings.
How Deminn cites itRecords and deviations link to the protocol revision they belong to, so the chain survives an amendment.
ISO 13485ISOQuality management systems for medical devices
The international QMS standard. Recognised by FDA QMSR (2026), Health Canada, MDSAP, and EU notified bodies.
Sub-clauses indexed§5.6.2Management review inputs§7.3Design and development§8.2.2Complaint handling§8.5.2Corrective action
What inspectors look forNotified-body audits flag missing management-review inputs more than any other §5.6.2 issue.
How Deminn cites itReview packets aggregate KPIs, complaint trends, MDRs, and CAPA aging into the §5.6.2 list automatically.
ISO 14971ISOApplication of risk management to medical devices
The risk-management standard. Hazard ID, risk estimation, evaluation, and control across the lifecycle.
Sub-clauses indexed§4.4Risk management plan§5.4Hazard identification§7Evaluation of overall residual risk§10Production and post-production activities
What inspectors look forAuditors check whether the risk file was updated when post-market data showed a new hazard.
How Deminn cites itNew PMS signals trigger a risk-file diff so hazard, risk, and residual-risk stay current with field data.
A generic Part 820 citation is what gets flagged. The specific sub-clause is what closes the gate.
Most AI tools cite “21 CFR 820” as a section label. That is exactly what inspectors flag. Deminn cites the specific sub-clause with the verbatim text - because the corpus tells us which patterns fail records on inspection.
Get drafts that an inspector would accept.
Pilots include a founder walkthrough of the corpus and the citation validator.