Medical Device Software Consulting
Expert Guidance for Navigating the SaMD Landscape
Hi, I’m Paul.
I created Paul Lamoreux Consulting to specialize in guiding companies through the complex and regulated world of medical device software. That includes Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
With a four-decade foundation in software development and engineering leadership across multiple industries, years of adapting to the stringent requirements of medical device compliance, and now deep study and practice using AI, I bring a unique combination of expertise in software, quality, and compliance strategies.
My role is to bridge the gap between your software teams and the complex world of regulatory compliance.
I work alongside you and your software team to understand your product, develop the necessary documentation for cybersecurity, design control, risk management, and more. From project start to clearance, I help your company meet the latest regulatory and cybersecurity requirements while preparing for post-market activities.
In essence, I help you transition from being a software developer to a Medical Device Software Manufacturer — a distinction with significant implications.
Whether you’re just starting to develop a medical device software product or preparing for submission and post-market success, I provide the expertise and hands-on support to help you succeed.
FIXED PRICE, FAST TURNAROUND
Cybersecurity Submission Jumpstart
Struggling with FDA Cybersecurity Requirements? Start Here
This service delivers a fast, expert-driven assessment of your existing materials and provides a concrete, prioritized action plan to get to submission ready. With the FDA’s 2023 guidance now actively enforced, many teams find themselves unsure if their documentation is complete — or even on the right track.
If you’re unsure how to meet the FDA’s evolving cybersecurity requirements, this Jumpstart gives you clarity, direction, and confidence to move forward — without wasting time or budget.
All Services
I help software teams tackle the hardest parts of medical device compliance. From early design control and risk management to cybersecurity and submission-ready documentation, I focus on the high-leverage work that moves your SaMD product forward.
Whether you’re just starting to formalize your development process or closing gaps before FDA submission, I deliver expert guidance, practical support, and tailored solutions that align with your product, your team, and your timeline.
My goal is to help you make faster progress, avoid costly missteps, and build the foundation for long-term regulatory success — without slowing down innovation.
“Excellence is never an accident. It is always the result of high intention, sincere effort, and intelligent execution.”
– Aristotle
Get in Touch
Click below if you are interested in talking about your plans for your medical device software project