Regulated software for devices that cannot fail.
IEC 62304-compliant software development for medical devices. Twenty-seven years across ultrasound, defibrillators, and research platforms.
Medical device software has to work. It has to be traceable, verifiable, and auditable. The standards — IEC 62304, ISO 14971, QSR 820 — are not optional. Your team needs someone who has shipped regulated software and can write the code and the documentation.
I develop medical device software from requirements through verification. I have worked on Class C devices (defibrillators), Class II ultrasound platforms (SonoSite, Verasonics), and research instrumentation. I write the software and the documentation — hazard analysis, traceability matrices, verification plans. I served as Director of Global Quality at SonoSite, so I know what auditors look for.
Software requirements and architecture documentation
Source code with traceability to requirements
Hazard analysis and risk management documentation (ISO 14971)
Verification and validation test plans and results
Software development plan (IEC 62304 compliant)
Scope, device classification, and regulatory path determine the price. We will propose a fixed fee or milestone-based engagement.
How it works
Scope and classify
Define the device classification, the applicable standards, and what done means for your regulatory path.
Plan and document
Software development plan, hazard analysis kickoff, and traceability structure.
Build with evidence
Develop the software while building the verification trail — traceability, unit tests, integration tests.
Verify and hand off
Final verification, documentation package, and handoff ready for audit or submission.
Why this matters
Software written by someone who has been audited and passed
Documentation that auditors will accept
Twenty-seven years of medical device experience in one engagement
Former Director of Global Quality — I know what regulators need
Domains we have worked in
Ready to get started?
Tell us what you need. We will tell you if it is a fit and what happens next.
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