From concept to cleared, with the paper trail to prove it.
I help medical device teams build the software documentation, risk management, and verification & validation record that regulators expect — without slowing your engineering team down.
Documentation that holds up under review.
Software lifecycle documentation
Development plans, software requirements, architecture descriptions, and traceability matrices, structured the way reviewers expect to find them.
Risk management & design controls
ISO 14971 risk analysis, hazard identification, and design control documentation tied directly to your actual design decisions.
Verification & validation
V&V planning, protocol and test case authoring, execution support, and defect triage alongside your engineering team.
Regulatory submission readiness
FDA pathway guidance, ISO 13485/IEC 62304 alignment, and SOP/work instruction authoring so submission day isn't a scramble.
Cross-functional bridging
Translating clinical and scientific input into engineering requirements, and coordinating product, engineering, QA, and regulatory teams around one plan.
Built for early-stage teams
Comfortable stepping into a startup with an early QMS, and comfortable working inside an established one that already has strong process.
A sample of the problems I've been brought in for.
Biofeedback device for pelvic floor therapy
Engaged by an early-stage startup as an external software consultant to guide mobile app development from concept toward regulatory clearance — authoring the software development plan, requirements, architecture, risk management file, and cybersecurity documentation, while coordinating directly with the development team on design and implementation.
Intraoperative imaging & surgical guidance
Led development of AI-assisted intraoperative annotation and guidance software for orthopedic surgery at a startup. Maintained the full design history file to ISO 13485 / IEC 62304 and advised on technical feasibility and timelines.
Rapid-PCR infectious disease detection platform
Leads a cross-functional team delivering roughly 30 regulated diagnostics software releases a year at an established IVD company, including championing a large-scale re-architecture to reduce cybersecurity risk and improve development throughput.
Engineering
Led by Dr. Todd.
I hold a Ph.D. in Biomedical Engineering from the University of Utah, where my research translated computational joint-mechanics models into clinical tools. Since then I've worked on both sides of the table — building regulated software as an engineering leader, and guiding other teams' software through the same process as a consultant.
That combination is the point: I've felt the pressure of a real release deadline, and I know exactly what a reviewer is going to ask for. I bring both into every engagement.
- Ph.D., Biomedical Engineering — University of Utah
- Software lifecycle & QMS documentation under ISO 13485 / IEC 62304
- Risk management under ISO 14971
- Worked in mobile apps, connected hardware, custom towers
- FDA 510(k) submission support
Tell me about your device.
Share a bit about where your product is in its lifecycle and what you need help with. I typically reply within two business days.