Prepare for FDA inspections with confidence. I help medical device companies achieve audit-ready status through Design History File (DHF) development, Device Master Record (DMR) compliance, and pre-audit gap assessments. Specializing in FDA 21 CFR Part 820 requirements for product development.
Build a foundation for compliant product development. I develop and operate Quality Management Systems, create product requirements, and design verification plans with complete traceability. Experience with DO-178C and medical device validation protocols.
Break down silos and align your teams. I work side-by-side with your organization to identify pain points, facilitate cross-functional communication, and establish better ways of working together. Turn "talking at each other" into "speaking with each other."
Managed all system requirements, verification, and regulatory compliance for the G500 TXi flight display system. Set the standard for system requirements management at Garmin, establishing processes that became the benchmark for subsequent aviation product development.
Led cross-functional launch verification efforts at Virgin Orbit, coordinating with all departments to ensure testing supported a high probability of successful launch. The mission achieved orbit insertion on first flight.
Led launch of multiple Software as a Medical Device (SaMD) applications including a Type I Diabetes application, a Type 1 Diabetes dosing guidance SDK, and the MyWay companion application for Dupixent.
Mapped the entire ecosystem of information across the Oregon State Hospital system. Identified critical gaps and led initiatives that resulted in closure of 3 enterprise risks, significantly improving patient data integrity and operational workflows.
Ronning Systems, LLC is a technology consultancy founded on the principle that great systems don't happen by accident—they're designed, built, and maintained with care.
The best solutions are often the simplest ones. We avoid over-engineering and focus on what matters.
Systems should work when you need them. We build with redundancy, monitoring, and graceful degradation in mind.
No black boxes. We document our work and ensure you understand your own systems.
We succeed when you succeed. Long-term relationships over quick fixes.
With years of experience in software development, cloud architecture, and systems engineering, we bring a practical, business-focused approach to technology. We've worked with startups and established enterprises, always focusing on delivering real value.
Ready to discuss your project? Get in touch.