Cullom Cahill

Design Controls & Traceability for SaMD Companies

I help early-stage Software as Medical Device (SaMD) teams build FDA-compliant quality systems without slowing down development.Ideal for: Pre-revenue to Series B teams implementing Quality Management Systems.Former Quality Engineering Manager in Mental Health Tech | 3 years managing design controls through FDA 510(k) submissionNot sure what you need yet?
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Services

I refuse to let startups get lost in the weeds of regulatory compliance. I help you build a right-sized QMS that won't compromise your most valuable asset: speed.I work alongside your engineering & product teams to operationalize design controls so you do not get stuck in regulatory theory.Design Control Setup | Templates, DHF structure, & trainingMatrix/Greenlight Guru Setup | Traceability workflows & onboardingV&V Planning | Requirements to test protocols to documentationChange Control Workflows | Compliance without velocity loss

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About

I spent 3 years as Quality Engineering Manager at Woebot Health, where I established design control processes on the engineering side and managed requirements traceability through FDA 510(k) submission. Working alongside regulatory consultants who handled formal documentation, I created and trained teams on the operational workflows that made design controls actually work in an agile development environment.I understand the tension between moving fast and staying compliant. I've lived it and I know how to make both work.Before quality systems, I ran a custom carpentry business. I bring the same precision and craftsmanship to building quality systems that I brought to building furniture: careful, intentional, built to last.

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