Matrix Quality for Software as a Medical Device (SaMD)

SaMD companies need a quality system that moves at the pace of software. Matrix Quality is a validated, cloud-based eQMS that fits lean teams and fast release cycles — without cutting corners on compliance.

The challenge
Our solution

Common workflows

Quality processes built for SaMD teams.

Controlled document and SOP managementManage quality system documentation with controlled approval workflows, version control, and electronic signatures — aligned to 21 CFR Part 11 and EU Annex 11.

  • Structured review and approval

  • Version control with full history

  • Electronic signature compliance

Software change controlRoute all software changes through a documented review and approval process with impact assessment and audit trail.

  • Change request workflow

  • Impact assessment documentation

  • Full approval and closure audit trail

Post-market surveillance and complaint handlingTrack customer complaints and post-market feedback with a structured investigation workflow linked to CAPA and change control.

  • Complaint intake and triage

  • Investigation and root cause analysis

  • Link to CAPA and change control

Training for distributed teamsAssign training to remote and distributed teams, track completion, and maintain qualification evidence — all in one system.

  • Role-based training assignment

  • Completion tracking for distributed teams

  • Training matrix with real-time visibility

Hear from our customers

Roche

Matrix Quality gives us a single, validated system for our entire quality process. Audits that used to take weeks of preparation now take days.

Quality Director, Life Sciences Company

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies