Rigorous verification and validation for medical devices and software — ensuring patient safety, regulatory compliance, and market readiness across IEC 62304, ISO 14971, and FDA standards.
End-to-end verification and validation services for medical devices, embedded software, and health-tech applications.
Complete device-level validation including hardware/software integration testing, environmental testing, EMC/EMI compliance, biocompatibility verification, and production validation (IQ/OQ/PQ).
Software lifecycle management per IEC 62304 — requirements traceability, unit testing, integration testing, static analysis, code reviews, and software safety classification (Class A/B/C).
FDA 21 CFR Part 11 compliance for electronic records, 510(k) submission support, Design History File (DHF) creation, and pre-market notification documentation.
End-to-end risk management per ISO 14971 — hazard analysis, risk estimation, FMEA/FTA, risk control measures, benefit-risk analysis, and residual risk evaluation across the device lifecycle.
User-centered design validation per IEC 62366 — use specification, task analysis, formative evaluations, summative usability testing, and use error risk analysis for medical device interfaces.
Medical device cybersecurity assessment, data integrity validation, HIPAA compliance testing, secure communication protocols, and vulnerability management for connected health devices.
We embed regulatory compliance into every phase of the development lifecycle — from design inputs through post-market surveillance — ensuring your device meets the highest safety and quality standards.
Our V&V processes are designed to systematically identify, evaluate, and mitigate risks to patient safety. Every test case, every review, every documentation artifact traces back to protecting the end user.
Partner with us for regulatory-compliant verification and validation that accelerates your time to market.
Get a Quote