Vero AI for Healthcare & Medical Devices

Audit-Ready Evidence For Every Patient Record, Device File, andFramework.

Vero AI applies formal control and regulatory logic to patient data access logs, quality system records, device history files, and vendor submissions — evaluating evidence against HIPAA, HITRUST, SOC 2, NIST CSF, ISO 13485/QMSR, GDPR, and custom control sets built for providers and device manufacturers.

Request a demo See frameworks we support

Record scan1 / 4 scanning

Patient recordPHI · access & retention

Device fileDHF · CAPA · complaints

access_eventEHR read · user 4471 · 02:14

dhf_sectionDesign history · rev C

minimum_necessaryRole scope verified

capa_recordCAPA-0192 · closed 11d

audit_trailImmutable · 6y retention

e_signaturePart 11 binding · valid

breach_reviewNo reportable event

complaint_intakeMDR triage · 3d median

HIPAA §164.312(b)ISO 13485 §7.3HITRUST 01.cQMSR 820.10021 CFR Part 11SOC 2 CC7.2HIPAA §164.400ISO 13485 §8.2

One pass — patient and device evidence evaluated together

The unaddressed gap

Patient data and device quality evidence still live in silos

Healthcare providers and medical device manufacturers generate some of the most heavily regulated evidence of any industry — and most of it never reaches the GRC system in a form an auditor, a notified body, or an FDA investigator can trust.

Before Vero AI — broken chain of custodyWith Vero AI — continuous chain of custody

PHI access logs and audit trails reviewed by hand, system by system, department by department.

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Every access log and audit trail evaluated against the same standard, every time.

Device history files and CAPA records assembled by hand ahead of an FDA inspection.

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Device history files and CAPA evidence tested continuously, ready before the inspection.

Quality records disconnected from the ISO 13485 clause or QMSR requirement they support.

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Full links from framework clause through evidence through finding.

HITRUST and SOC 2 evidence collected once a year, under deadline pressure.

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Results in minutes, not weeks — ready before the auditor or the investigator asks.

Evidence evaluation for

Frameworks healthcare & medical device companies are held to

Vero AI already supports these standards out of the box. Custom frameworks are available as well, built the same way our named frameworks are — clause by clause, evidence type by evidence type.

All frameworksProviders & payersDevice makersBoth

HIPAA+

Providers & payers

Privacy and Security Rule evidence — PHI access logs, risk assessments, and breach-notification records evaluated clause by clause.

HITRUST CSF+

Providers & payers

SOC 2 & SOC 1+

Providers + device makers

NIST CSF & GDPR+

Providers + device makers

FDA QMSR / ISO 13485+

Device makers

IEC 62304 & ISO 14971+

Device makers

FDA Premarket Cybersecurity (Sec. 524B)+

Device makers

21 CFR Part 11 & EU MDR+

Device makers

Custom Control Sets+

Providers + device makers

Two verticals, one evidence layer

Built for the care setting and the device file

Healthcare providers and medical device manufacturers share the same underlying problem — highly regulated, document-heavy compliance evidence — but the specific frameworks and failure modes differ.

Healthcare Providers & Payers

Hospitals, health systems, and health plans managing patient data, vendor risk, and accreditation across every facility.

• ​▪HIPAA Privacy & Security Rule evidence tested clause by clause, system by system
• ​▪HITRUST CSF evidence required by payer and hospital-system vendor contracts
• ​▪Business-associate and vendor risk evidence evaluated at every audit cycle
• ​▪SOC 2 and NIST CSF controls for connected clinical and IT systems

Medical Device Manufacturers

Device makers managing design controls, quality systems, and cybersecurity across the product lifecycle.

• ​▪FDA QMSR / ISO 13485 quality system evidence, evaluated clause by clause
• ​▪IEC 62304 software lifecycle and ISO 14971 risk-management records
• ​▪FDA premarket cybersecurity (Sec. 524B) evidence for connected devices
• ​▪21 CFR Part 11 and EU MDR technical-file readiness for global distribution

One evidence layer · one evaluation engine · every framework

Chain of custody

Follow one record from evidence to workpaper

Every finding Vero AI produces carries an unbroken thread back to the record it came from and the clause it was tested against. Pick an artifact to trace it.

PHI access log

EHR audit trail export · 41,208 events

Device history file

Lot 4471 · design & production records

Complaint & CAPA record

CAPA-2026-118 · postmarket complaint chain

Vendor / BAA submission

Business associate packet · 18 documents

SBOM & threat model

Connected infusion platform · v4.2

EvidenceFramework clauseEvaluationFindingWorkpaper

Clause

HIPAA §164.312(b) — Audit controls

Evaluation

Every access event checked for role authorization, break-glass justification, and review sign-off within policy window.

Finding

3 break-glass accesses with no documented justification inside 72 hours.

Tested once · credited to

HIPAAHITRUST CSFSOC 2NIST CSF

What you can achieve with Vero AI

• ​

  Unlimited Unlimited — Frameworks supported today Frameworks supported today

• ​

  <0 min <1 min — To first evaluated finding To first evaluated finding

• ​

  0% 100% — Controls tested to one standard Controls tested to one standard

• ​

  0 1 — Evidence layer for every framework Evidence layer for every framework

Healthcare & medical device FAQs

HIPAA, HITRUST, and FDA evidence — answered

What is HIPAA compliance software, and how is Vero AI different?+

Most HIPAA compliance software stores policies and tracks tasks — it does not read the evidence. Vero AI evaluates the evidence itself: PHI access logs, audit trails, risk assessments, and business-associate submissions are tested against the actual language of the Privacy and Security Rules, and every finding cites the record and the clause it came from.

Can Vero AI support HITRUST CSF and SOC 2 at the same time as HIPAA?+

Yes, and that overlap is the point. Controls shared across HIPAA, HITRUST CSF, SOC 2, and NIST CSF are tested once against your evidence and credited to every framework that relies on them, so a health plan's HITRUST requirement and a customer's SOC 2 request draw from the same evaluated evidence rather than two parallel efforts.

How does Vero AI handle FDA QMSR and ISO 13485 quality system evidence?+

FDA's Quality Management System Regulation took effect February 2, 2026 and incorporates ISO 13485:2016 by reference. Vero AI evaluates device history files, design control records, complaint handling, and CAPA evidence clause by clause against QMSR and ISO 13485, producing traceable workpapers you can hand to a notified body or an FDA investigator.

Does Vero AI cover medical device cybersecurity under Section 524B?+

Yes. SBOMs, threat models, and postmarket vulnerability-handling evidence for cyber devices are evaluated against FDA's premarket cybersecurity expectations, with IEC 62304 software lifecycle and ISO 14971 risk records assessed alongside them so a single software change is reviewed once across all three.

Can 21 CFR Part 11 electronic records and signatures be evaluated automatically?+

Yes. Records subject to Part 11 are tested for signature attribution, audit-trail completeness, and record integrity, and the same evidence carries into EU MDR technical-file readiness for globally distributed devices.

Do we have to replace our EHR, QMS, or GRC system?+

No. Vero AI is the evaluation layer, not a system of record. It reads evidence out of the systems you already use — EHR, eQMS, document management, GRC, shared drives — and returns audit-ready workpapers your team, your auditor, or an FDA investigator can trace end to end.

Vero AI for your industry

HR & Hiring▾

AI bias audits and adverse impact analysis, evaluated against every hiring regulation you operate under.

Professional Services, Audit & Accounting▾

Manufacturing & Construction▾

Finance & Internal Audit▾

HR & Hiring

One bias audit. Every hiring jurisdiction.

• ​✓Selection-rate and adverse impact analysis run on live hiring data
• ​✓Evaluated against NYC LL144, Colorado AI Act, EU AI Act, and Title VII
• ​✓Auditor-ready workpapers instead of a spreadsheet a consultant built once

Explore HR & Hiring→

Ready to make patient and device evidence audit-ready?

See how Vero AI evaluates your access logs, quality records, and vendor submissions against every framework your organization is held to.

Request a demo See how evidence evaluation works

Every record, every clause

HIPAAHITRUST CSFSOC 2 & SOC 1NIST CSF & GDPRFDA QMSR / ISO 13485IEC 62304 & ISO 14971FDA Premarket Cybersecurity (Sec. 524B)21 CFR Part 11 & EU MDRCustom Control Sets

Tested once · credited across every framework