Services
Paul Lamoreux Consulting helps software teams move faster and smarter toward FDA submission — with expert-driven services that bridge the gap between development and compliance.
Whether you need a fast, fixed-price audit of your cybersecurity documentation or custom support translating engineering work into regulator-ready artifacts, I focus on these high value activities:
Getting your documentation clear, complete, and aligned with FDA expectations
Reducing the risk of delays, rework, or regulatory pushback
Empowering your team with the tools and guidance to succeed at every stage
I don’t sell boilerplate. I work hands-on with your team to deliver high-quality documentation and processes — tailored to your company, your product, your risks, and your tech stack.
FAST TURNAROUND, FIXED PRICE
Cybersecurity Submission Jumpstart
Get a clear, expert-driven plan to prepare your SaMD cybersecurity documentation for FDA submission — without wasting time or budget.
The Cybersecurity Submission Jumpstart gives medical device software teams a fast, focused audit of their existing cybersecurity documentation and a strategic action plan to reach 510(k) submission readiness.
In just two weeks, you’ll receive a personalized gap analysis and a detailed roadmap that spells out what’s missing, what needs to be created, and how to prioritize each step.
This service helps you move faster, avoid rework, and reduce regulatory risk — by giving you a clear, actionable plan grounded in current FDA expectations. No more second-guessing or spinning wheels. Just clarity, direction, and confidence.
Strategic Support Beyond Jumpstarts
In addition to my fixed-price Cybersecurity Submission Jumpstart service, I offer targeted consulting for software teams that need to align development with regulatory expectations.
I specialize in:
Design Control & Documentation
Creating and reviewing the full design matrix — user needs, design inputs and outputs, verification and validation — and ensuring everything is complete.
Risk Management (Safety & Cybersecurity)
Developing risk management frameworks aligned with ISO 14971 and FDA cybersecurity guidance, with traceability from identified risks to implemented controls.
Cybersecurity & Technical Documentation
Producing submission-grade artifacts such as SBOMs, architecture diagrams, threat models, and risk control plans that bridge engineering reality with regulatory clarity.
QMS Support
Designing or refining QMS elements that impact software development teams, including design controls, document management, and configuration practices.
These services are offered through custom engagements tailored to your team’s specific challenges and regulatory goals.
Not sure where to start? Let’s talk. I’ll assess your current state and map out a focused plan.
More Jumpstarts are Coming
Jumpstarts are fast, fixed-price services designed to give your team immediate momentum on a critical regulatory challenge.
Each one delivers a focused burst of expert guidance and hands-on support — helping you skip the confusion, avoid false starts, and make real progress.
In a short, structured engagement, we review your existing document, clarify needs via interviews with your stakeholders, and deliver high-value outputs like gap analyses, customized starter documentation, and/or prioritized action plans.
The result? Clarity, confidence, and a strong head start — without wasting time or budget.
Be on the lookout for these new Jumpstart programs coming soon:
Design Control Jumpstart
Risk Management Jumpstarts (Safety and Cybersecurity)
QMS Essentials Jumpstart
Technical Documentation Jumpstart