ClinixQM

Quality management and compliance for medical device and healthcare software teams

The Complete QMS Workspace

ClinixQM is the complete workspace for medical device and healthcare software teams. Manage documents, risks, CAPAs, training, and compliance evidence in one place. Get audit-ready faster.

Built specifically for the regulatory requirements of medical technology, ClinixQM streamlines your quality management processes while maintaining the rigorous documentation standards required for compliance.

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The Challenge

Medical device and healthcare software companies face complex regulatory requirements across multiple standards and jurisdictions. Managing quality documentation, risk assessments, and compliance evidence across disconnected systems leads to inefficiency, audit anxiety, and increased regulatory risk.

Traditional QMS solutions are often cumbersome, expensive, and not designed for the specific needs of healthcare technology teams working under ISO 13485, IEC 62304, and other medical device regulations.

Our Solution

ClinixQM brings all your quality management activities into a single, purpose-built platform. From document control to risk management, from CAPA tracking to training records, everything is connected and audit-ready.

The platform is designed by teams who understand medical device development, ensuring workflows align with how healthcare technology companies actually work while maintaining full regulatory compliance.

Key Features

Document Control

  • Version-controlled document management
  • Approval workflows with electronic signatures
  • Document templates for common regulatory needs
  • Full audit trail and change history

Risk Management

  • Risk assessment and FMEA tools
  • Risk-benefit analysis documentation
  • Traceability to design controls
  • Risk monitoring and review workflows

CAPA Management

  • Corrective and preventive action tracking
  • Root cause analysis tools
  • Effectiveness verification workflows
  • Integration with complaint handling

Training & Compliance

  • Training record management
  • Competency tracking and assessment
  • Compliance evidence organisation
  • Audit preparation tools
Who It's For

Medical Device Companies developing hardware, software, or combination products who need to maintain ISO 13485 compliance and prepare for regulatory submissions.

Healthcare Software Teams building clinical applications under IEC 62304 who need to manage software lifecycle documentation and risk management.

Quality & Regulatory Professionals responsible for maintaining QMS compliance and preparing for notified body audits and regulatory inspections.

Startups & Scale-ups establishing their first QMS or transitioning from spreadsheet-based systems to a scalable quality management platform.

Ready to streamline your QMS?

Get audit-ready faster with ClinixQM. Visit our dedicated platform to learn more.

Visit ClinixQM