Medical Devices & Healthcare
Medical device and health IT software where every requirement must trace to its implementation.
- → Software for FDA-regulated systems
- → Traceability across the IEC 62304 lifecycle
- → HIPAA-aware data handling and security review
- ✓ Embedded in a Fortune 500 medical device maker's R&D team since 2024
- ✓ HIPAA-compliant case management that passed security audits
FDA 21 CFR Part 11IEC 62304HIPAA