Precision hardware meets compliant software.
Quality management automation, SaMD engineering, design control traceability, and regulatory compliance for medical device and in vitro diagnostics manufacturers.
Four places device programs lose momentum.
From design freeze to post-market surveillance, the engineering must satisfy auditors and users alike.
Design Control & Traceability Matrix Friction
Maintaining bidirectional traceability across user needs, product requirements, risk analyses, and verification test protocols in fragmented tools creates major audit vulnerabilities.
We engineer automated Design History File (DHF) and traceability pipelines that link requirements, CAD models, software commits, and test outputs with unbroken audit logging.
510(k), De Novo & PMA Submission Overhead
Assembling hundreds of mechanical, electrical, and clinical validation records into submission-ready FDA eSTAR or EU MDR technical documentation stalls commercial launch timelines.
We implement automated regulatory dossier compilation engines that ingest test telemetry, generate formatted technical files, and validate compliance against target authority templates.
Connected Device IoT & Post-Market Surveillance
Device manufacturers struggle to securely ingest, process, and analyze continuous telemetry from distributed hardware fleets while complying with FDA post-market surveillance mandates.
We architect high-throughput, HIPAA/SOC2-compliant IoT lakehouses that stream device health telemetry, detect anomalies in real time, and automate adverse event triaging.
SaMD Lifecycle & IEC 62304 Software Validation
Software as a Medical Device (SaMD) and connected diagnostics require rigorous software lifecycle documentation and cybersecurity validation that standard agile teams struggle to satisfy.
We establish compliant CI/CD and automated test harnesses enforcing IEC 62304 standards, static analysis, SBOM generation, and continuous cybersecurity posture monitoring.
Built for device innovators.
Every engagement is designed around your device classification, your software safety class, and your regulatory submission roadmap.
Start a Technical ConversationAccelerate device clearance.
If design controls are slowing down iteration cycles, post-market data is disconnected from quality engineering, or SaMD validation is blocking release, let's build the systems that clear the path.
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