MedTech Regulatory Intelligence

Regulatory intelligence, on demand

Automated compliance monitoring for FDA, EU MDR/IVDR, and ISO 13485. Run a workflow, get an actionable report. Pay only per run — no subscription.

Request a DemoRun your first workflow
FDA 21 CFR
Part 820 + 803
EU MDR/IVDR
2017/745 + 2017/746
ISO 13485
:2016 Medical Devices
$49
Per workflow run
Why Regulio

Full regulatory coverage

FDA 21 CFR Part 820/803, EU MDR 2017/745, IVDR 2017/746, and ISO 13485:2016 — all in one platform. No patchwork of tools.

Instant, actionable reports

Each workflow run produces a structured compliance report with gap analysis, risk flags, and remediation priorities — ready in minutes.

No subscription lock-in

Pay $49 per workflow run. Use it when you need it — pre-submission audits, periodic reviews, or after regulatory changes.

Process

Three steps to compliance clarity

01

Select regulation scope

Choose which regulations apply — FDA, EU MDR/IVDR, ISO 13485, or a combination. Define your device class and submission context.

02

Run the workflow

Upload your technical documentation or connect your QMS. Regulio runs automated checks against the selected regulatory requirements.

03

Get actionable report

Receive a structured report with compliance status, identified gaps, risk ratings, and prioritized remediation actions.

Designed for regulatory affairs professionals and QMS managers at MedTech companies navigating global submissions.

See it in action
Coverage
FDA

U.S. FDA Compliance

  • 21 CFR Part 820 — QSR
  • 21 CFR Part 803 — MDR
  • 510(k) submission readiness
  • PMA design controls
EU MDR/IVDR

European Regulations

  • MDR 2017/745 compliance
  • IVDR 2017/746 compliance
  • Technical documentation review
  • Post-market surveillance
ISO 13485

Quality Management

  • ISO 13485:2016 gap analysis
  • QMS process coverage
  • Risk management per ISO 14971
  • CAPA effectiveness checks
Pricing

Pay per run. Nothing else.

No monthly fees, no seat licenses, no surprise invoices. Run a workflow when you need it.

Most popular

Regulatory Workflow Run

Single compliance scan + full report

$49
per run
Regulatory gap analysis
Risk-flagged findings
Prioritized remediation plan
Exportable PDF report
Covers FDA, EU MDR/IVDR, or ISO 13485
Run your first workflow

Volume pricing available for 10+ runs/month. Contact us

Ready to simplify compliance?

Join MedTech regulatory teams using Regulio to accelerate submissions and maintain continuous compliance.

Request a DemoStart now — $49/run