Medical Devices
IEC 62304, ISO 13485, and FDA-ready traceability. Built for medical device software teams that put patient safety first.
Medical Device Software Challenges
Patient Safety
Software failures can harm patients. IEC 62304 mandates rigorous development processes, risk management, and complete traceability.
FDA Submissions
510(k), PMA, and De Novo submissions require comprehensive Design History Files (DHF) — compiling them manually is error-prone.
Post-Market Surveillance
CAPA tracking, complaint handling, and adverse event reporting must be linked back to the original requirements and design decisions.
How Arcadia Helps
IEC 62304 Class A/B/C
Pre-configured workflows for all software safety classes. Automatic traceability from software requirements to architecture, detailed design, and unit verification.
ISO 14971 Risk Management
Integrated risk management with FMEA templates. Link hazards to software items, risk control measures, and verification results.
FDA Submission Ready
Generate complete Design History Files (DHF) with one click. Traceability matrices that map requirements → design → implementation → verification → validation.
CAPA & Complaints
Track corrective actions and link them to the affected software items. Maintain a living audit trail from complaint to code change.