One Partner. Every Stage.
From IEC 62304-compliant software engineering to FDA-aligned AI/ML systems — we cover every stage so you don't have to stitch together multiple vendors or hand off compliance documentation at the finish line.
What We Do
Every service area is staffed with engineers who work inside the standards daily — not consultants who learn them on your project.
IEC 62304-compliant engineering across the full software development lifecycle — from architecture, embedded systems, and cloud integration through V&V and audit-ready DHF assembly.
FDA-aligned AI/ML SaMD development, clinical decision support systems, and Predetermined Change Control Plan documentation that keeps your model update pipeline compliant.
End-to-end 510(k) preparation, ISO 14971 risk management, Quality System Regulation documentation, and Design History File assembly — built in from day one, not bolted on at the end.
From concept to cleared product — connected medical devices, cloud health data platforms, IoT architectures, and legacy system modernization with full regulatory traceability.
Why One Partner
When your software engineers, AI developers, and regulatory writers are different vendors, documentation diverges, traceability breaks, and submissions get rejected. We eliminate that risk.
Single source of truth
Requirements, architecture, risk controls, and test cases all live in one traceable DHF — authored by the same team.
Regulatory continuity
The engineer who wrote the SRS is the same one who writes the 510(k) software section. No interpretation loss.
AI + compliance, integrated
AI workflow decisions are made with regulatory impact in mind from the start — not reviewed for compliance after deployment.
Scalable across device classes
Whether Class I software utility or Class III AI-driven diagnostic — the same rigorous process, scaled to the risk.