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Development of ISO/IEC 62304 Compliant Python-Based Diagnostic Software for Cancer Detection

revolve.healthcare

Medical

Information technology

Software development

Regulatory Compliance and Software Modernization Challenge

Need to redevelop legacy MATLAB diagnostic scripts into a compliant, production-ready Python solution with automated testing and comprehensive documentation to meet ISO 13485, IEC 62304, and IVDR risk class C requirements while maintaining diagnostic accuracy.

About the Client

A scientific research group specializing in cancer diagnostics using photonics and machine learning technologies.

Key Development Goals

Translate MATLAB algorithms into production-grade Python code
Implement ISO/IEC 62304-compliant software development lifecycle processes
Create automated testing framework with 100% code coverage
Develop cross-device compatibility for multiple spectrometer brands
Establish lean documentation system aligned with medical device regulations

Core System Requirements

Multi-spectrometer data ingestion interface
Automated binary diagnostic result generation
Real-time data processing pipeline
Comprehensive audit trail system
Regulatory-compliant user authentication

Technology Stack

Python

Docker

FastAPI

Jira

Confluence

System Integrations

Laboratory spectrometer APIs
Client's Quality Management System (QMS)
Medical device regulatory documentation portals

Critical Non-Functional Requirements

ISO/IEC 62304:2006 compliance for medical device software
99.9% system availability with Docker containerization
End-to-end encryption for patient data protection
Scalable architecture for future diagnostic modules
Real-time performance monitoring dashboard

Expected Business Impact

Enables early cancer detection with 95%+ accuracy through automated spectroscopy analysis, reducing diagnostic time by 70% while ensuring compliance with EU IVDR regulations. Creates foundation for commercial deployment across European healthcare institutions.