Everything you need.
Nothing you don't.

Six modules. One platform. Built by medical device engineers who know what auditors actually look for.

📄

Document Control

The backbone of any QMS. Version control that actually works, with approval workflows that don't make you want to throw your laptop.

  • Full version history with diff view between any two revisions
  • Configurable approval workflows — sequential or parallel
  • Periodic review scheduling with automated reminders
  • Document numbering with custom schemas
  • Watermarked PDF generation for controlled copies
  • Bulk import from existing file systems
Document Control
⚡

Quality Events

CAPAs, NCRs, complaints, deviations — all in one place with configurable templates that match how your team actually works.

  • Configurable event templates for CAPAs, NCRs, complaints, and deviations
  • Root cause analysis tools with fishbone and 5-why templates
  • Effectiveness checks with automated follow-up scheduling
  • Link quality events to documents, suppliers, and other events
  • Dashboard with open/overdue/closed metrics
  • Export to PDF for regulatory submissions
Quality Events
🔗

Supplier Management

Onboard, qualify, and re-evaluate suppliers without spreadsheets. Because your auditor deserves better than a pivot table.

  • Supplier onboarding questionnaires with customizable fields
  • Qualification workflows with approval gates
  • Scheduled re-evaluation cycles
  • Supplier scorecards and risk classification
  • Approved supplier list generation
  • Link suppliers to quality events and documents
Supplier Management
📋

Compliance Packs

Pre-built template packs so you're not starting from a blank page. Hit the ground running with ISO 13485.

  • ISO 13485 starter kit with 30+ document templates
  • Quality manual, procedures, work instructions, and forms
  • Pre-configured workflows that match the standard
  • Gap analysis checklist
  • Regularly updated as standards evolve
  • Community-contributed templates coming soon
Compliance Packs
🔍

Audit Trail

Every action logged. Every change tracked. When the auditor asks "who changed this and when," you'll have the answer in seconds.

  • Immutable audit log for every record
  • Who changed what, when, and why
  • Electronic signatures with 21 CFR Part 11 alignment
  • Filterable audit history by user, record, or date range
  • Export audit trails for regulatory submissions
  • No backdoor edits — ever
Audit Trail
🔔

Notifications

Stop chasing people for approvals. Automated alerts keep your QMS moving without you playing project manager.

  • Email alerts for pending approvals and assignments
  • Review reminders before documents expire
  • Training assignment notifications
  • Overdue task escalation
  • Configurable notification preferences per user
  • Digest mode for less inbox noise
Notifications

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