ReqChain
Quality Management for Medical Devices
Full traceability QMS for medical device software development
Regulatory Compliance Built-In
ReqChain ensures your medical device software development meets the most stringent global regulatory requirements.
The Challenge
Medical device software development demands rigorous documentation and traceability. Traditional approaches using spreadsheets and disconnected tools create compliance gaps and audit nightmares.
The Solution
ReqChain provides end-to-end traceability from user requirements through verification and validation, with automated compliance dashboards and audit-ready documentation.
Full Traceability Chain
Complete bidirectional traceability across the entire product lifecycle
User Requirements (URS)
Capture stakeholder needs and intended use
Software Requirements (SRS)
Functional and non-functional specifications
Verification
Test cases, protocols, and results
Validation
User acceptance and clinical evidence
Core Capabilities
Everything you need for compliant medical device development
Requirements Management
Create, version, and approve requirements at all levels with complete change history
Bidirectional Traceability
Link requirements forward and backward through the entire development lifecycle
Verification & Validation
Manage test cases, protocols, and evidence with automated status tracking
Audit Trail
21 CFR Part 11 compliant change tracking with electronic signatures
Document Generation
Export Design History Files (DHF) and Technical Files automatically
Compliance Dashboards
Real-time compliance status for ISO 13485, MDSAP, and EU MDR
Ready to Streamline Your Compliance?
Join medical device teams using ReqChain to achieve full traceability and regulatory compliance.