Cullom Cahill

Design Controls & Traceability for SaMD Companies

You've built traction. Now investors are asking about regulatory strategy, and your requirements are scattered, testing is informal, and regulatory debt is growingI help post-seed to Series A SaMD teams build FDA-ready quality systems without killing development velocity.Former Quality Engineering Manager in Mental Health Tech | 3 years managing design controls through FDA 510(k) submissionNot sure what you need yet?
Book a 30-minute clarity call — I’ll tell you if I can help or not.

• Services
• About
• Schedule a Call

• LinkedIn
• Email

© Cullom Cahill. All rights reserved.

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

• Back

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.

• Back