Device software carries a different burden than a typical web app - IEC 62304-aligned process, design controls, and a clear FDA pathway from day one. We've shipped software for implantable cardiac devices and intraoperative monitoring systems under exactly that discipline.
IEC 62304-aligned software development with regulatory submission support.
Medical imaging AI and signal analysis validated for clinical use.
Connected-device data pipelines from sensor to clinician dashboard.
Post-market surveillance infrastructure and continuous compliance monitoring.
"Real-time monitoring for implantable cardiac devices with remote programming, clinical alerts, and care team dashboards - built for accuracy the clinical team could trust."
We support IEC 62304-aligned engineering and regulatory submission preparation; the pathway strategy itself is typically defined alongside your regulatory affairs team.
Yes - we integrate into an existing quality management system rather than requiring you to adopt ours.
Yes - this is typically scoped through our Cloud & DevSecOps service line alongside continuous compliance monitoring.
Book a workshop to walk through your device architecture and regulatory timeline.