Six modules · one platform

A complete QMS,
built for medical device teams.

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 52 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 designed to support 21 CFR Part 11
  • 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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