Paul Lamoreux Consulting Revenue

About Paul Lamoreux Consulting

I started Paul Lamoreux Consulting to help medical device software teams navigate regulatory compliance with clarity, speed, and confidence. After decades in software engineering — and several years leading a successful 510(k) SaMD submission — I saw how many startups and technical teams struggle to meet FDA expectations without slowing down innovation. I work directly with founders, heads of engineering, and product teams to assess documentation gaps, build regulatory strategies, and accelerate submission timelines. My services include fixed-price jumpstart packages, cybersecurity audits, design control reviews, and full-spectrum guidance through the SaMD lifecycle — all tailored to how real software teams actually work. I support clients with hands-on implementation of regulatory documentation, including design control records, architecture diagrams, software risk files, and cybersecurity artifacts. I also help companies build submission-ready systems that align with design control, QMS, and risk management expectations. Whether you need an action plan or someone to write the documents with your team, I provide structured, practical support to get you through FDA review with fewer surprises and stronger results. Soon I’ll be releasing new Jumpstart services based on trained, domain-specific AI Agents to dramatically shorten the time necessary to start your design control matrix, your risk matrix (both safety and cybersecurity), and your QMS documentation. I speak the language of software and compliance, which means I can integrate regulatory requirements into engineering workflows without overwhelming your team. If you’re building regulated software and need someone who gets both the tech and the regulations — let’s talk.

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