A Unified Post-Market Compliance Platform for MedQAIR

MedQAIR is a European Authorised Representative supporting medical device manufacturers with regulatory, quality, and information security compliance across the EU, UK, Switzerland, and the United States. Their work focuses heavily on post-market obligations, where ongoing documentation, registrations, and coordination across economic operators are critical.

MedQAIR partnered with Cleffex to design and build MDIS, a secure digital platform to modernize and streamline post-market compliance operations.

Most regulatory tools prioritize pre-market approvals. MedQAIR identified a major gap once devices are already on the market.

Post-market compliance required constant collaboration between manufacturers, Authorised Representatives, importers, and distributors. This work was largely handled through email, shared folders, and spreadsheets, which created several challenges:

• Delays caused by fragmented file sharing and unclear responsibilities
  
  
• Manual data entry leading to inconsistencies and compliance risk
  
  
• Growing complexity from managing registrations across systems such as EUDAMED and other national databases
  
  
• Limited visibility and traceability across the economic operator chain
  
  

MedQAIR needed a centralized system that could support real-world regulatory workflows while maintaining strict access control and audit readiness.

Our Solution

Cleffex worked closely with MedQAIR to design a platform grounded in practical regulatory processes rather than generic document storage.

The approach included:

• Detailed requirement workshops involving all stakeholder roles
  
  
• Joint technical and architectural sessions to define a scalable, compliance-ready foundation
  
  
• Iterative, sprint-based development with regular demos and refinements
  
  
• Workflow diagrams and logic models to clearly map compliance and approval flows
  
  
• Review and enhancement of MedQAIR’s existing codebase for long-term maintainability
  
  
• Careful selection of technologies focused on security, flexibility, and future integrations

The MDIS platform delivered a unified, secure environment for post-market compliance.  Its recent ISO/IEC 27001:2022 certification validates that MDIS operates within a structured, continuously monitored information security framework.

Key outcomes included:

• Centralized access to compliance documentation across stakeholders
  
  
• Role-based permissions to protect sensitive regulatory data
  
  
• Fully traceable review and approval workflows
  
  
• Reduced duplication through a single, consistent data source
  
  
• Clear feedback loops for document verification and corrections
  
  
• Improved communication, transparency, and operational efficiency
  
  

MedQAIR moved away from fragmented tools to a structured, scalable platform that supports ongoing regulatory obligations with confidence.

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