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QMS for your stage and sector

Whether you're a startup building your first medical device or an established team managing multiple products, ClinixQM adapts to your needs.

Solutions by company stage

The right level of structure for where you are today, with room to grow.

Early Stage

Startups & Pre-Revenue

Building your QMS from scratch? Start with documents and training, then add risk and CAPA as you approach regulatory submissions.

  • Foundation plan with core document control
  • Pre-built SOP templates to accelerate setup
  • AI-assisted document creation
  • Easy upgrade path as you grow
Growth Stage

Preparing for Market

Getting ready for your first audit or regulatory submission? Full QMS capabilities with compliance tracking and audit pack generation.

  • Complete QMS core (docs, risk, CAPA, training)
  • Multi-market compliance tracking
  • Audit pack generation with shareable links
  • Design controls and traceability
Scale

Enterprise & Multi-Product

Managing multiple products, large teams, or selling into enterprise customers? SSO, API access, and trust framework tracking.

  • Everything in Growth, plus:
  • Enterprise SSO (OIDC/SAML)
  • API access for integrations
  • Trust framework tracking (SOC 2 readiness)

Solutions by sector

ClinixQM works across the regulated healthcare and medical device landscape.

Medical Device Hardware

Class I, II, or III devices under UK MDR, EU MDR, or FDA 510(k)/PMA pathways. Full design controls, risk management, and post-market surveillance.

Relevant frameworks: ISO 13485, ISO 14971, IEC 62366, IEC 62304

Healthcare Software (SaMD)

Software as a Medical Device under MDR, FDA, or other regulatory frameworks. Integrated software development lifecycle with QMS processes.

Relevant frameworks: IEC 62304, FDA Software Guidance, ISO 82304

Digital Health & Clinical IT

Health IT systems, clinical decision support, and connected health platforms. Clinical safety management and information security controls.

Relevant frameworks: DCB 0129, DCB 0160, ISO 27001, DTAC

In Vitro Diagnostics (IVD)

Diagnostic devices under IVDR or FDA 510(k) pathways. Performance evaluation, analytical validation, and clinical evidence.

Relevant frameworks: ISO 13485, IVDR, FDA IVD Guidance

Common use cases

How teams use ClinixQM day-to-day.

ISO 13485 Implementation

Build a compliant QMS from scratch with pre-built templates, gap analysis tools, and clear guidance on what documentation you need.

Audit Preparation

Get ready for certification or surveillance audits. Generate evidence packs, review compliance status, and ensure all records are audit-ready.

Technical File Compilation

Assemble technical documentation for regulatory submissions. Track requirements, link evidence, and generate submission binders.

Post-Market Surveillance

Collect and analyze post-market data. Manage complaints, track vigilance reports, and generate periodic safety update reports.

Supplier Qualification

Evaluate and approve suppliers with risk-based qualification processes. Monitor performance and maintain supplier audit schedules.

Change Management

Controlled change processes for products, processes, and systems. Impact assessment, approval workflows, and implementation tracking.

Find the right solution for your team

Talk to us about your specific requirements and regulatory landscape.

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