Strategic Solutions. Built for industries that change the world
QMC was founded on a simple belief: the best consulting comes from people who’ve actually done the work. With 13+ years experience leading programs from concept through commercialization across medical devices, digital health, life sciences, and regulated industries, we bring real-world expertise to every engagement.
Services
Program & Project Management
Leading complex cross-functional programs from concept through commercialization.
QMC brings PMP-certified program leadership and gold-standard methodologies to organizations that need more than coordination, they need execution. We design and implement program management systems build on proven frameworks of integrated master schedules, risk registers, governance structures, milestone tracking, and executive reporting that gives leadership real visibility into program health.
Whether you’re building infrastructure from scratch or bringing discipline to an existing program, QMC delivers the structure, accountability, and hands-on leadership that turns strategy into results
Regulatory consulting & Strategy
Strategic guidance on regulatory pathways, compliance navigation, and documentation support for medical devices and combination products.
QMC bring firsthand regulatory knowledge to organizations navigating one of the most complex landscapes in any industry. Having worked embedded inside FDA’s CDRH office and led combination product programs through US and EU regulatory approval, QMC provides strategic guidance grounded in how regulators actually think and evaluate submissions.
Our regulatory consulting spans FDA design control frameworks, risk management planning (IS 14971), quality systems (ISO 13485), and regulatory documentation support to help organization move through the regulatory process with clarity, confidence and fewer surprises.
Whether you’re defining your regulatory strategy early in development or preparing for submission, QMC helps you ask the right questions and make the right decisions before they become costly ones.
Commercialization & Launch Strategy
Taking products from development through successful commercial launch in the US, EU, and beyond.
Getting a product to market requires more than a great design and regulatory clearance. It requires coordinated execution across engineer, clinical, regulatory, quality, supply chain, and commercial teams all moving towards the same finish line at the same time.
QMC has led multiple products through FDA approval and commercial launch in both US and EU markets, brinign the cross-functionl leadership and launch readiness discipline that turns development programs into commercial available products.
From CMO coordination and supply chain readiness to go-to-market planning and post-launch support, QMC bring the operational rigor and real world evidence to make your launch land right the first time.
SME & Technical Writing
Documentation, evaluations, reports, and technical writing grounded in deep device development expertise.
Great technical writing in the medical device and life sciences space requires more than strong writing skills. It requires someone who understands the science, the regulatory frameworks, and the standards that govern how documentation is evaluated. QMC brings both.
QMC provides comprehensive technical writing support across the full product lifecycle - from protocols and reports to regulatory submissions, clinical evaluations, and quality documentation. Every deliverable is build on a foundation of firsthand device development experience, not just familiarity with templates.
Whether you need a single document or ongoing technical writing support across a program, QMC delivers documentation that is accurate, defensible, and submission-ready.
About
Founder & Principal, QMC
Michael Quirk, PMP
I started QMC because I believe the best consulting comes from people who’ve actually done the work, not just advised on it.
With 13+ years of experience leading complex programs across medical devices, combination products, digital health, and regulated industries, I’ve built programs from scratch, directed cross-functional teams of 40-50 people, navigated FDA submissions from both sides of the table, and launched products in the US and EU markets. I’ve worked inside early-stage startups with no playbook, inside Fortune 500 organizations with every stakeholder imaginable, and even inside FDA’s own CDRH office as an embedded contractor. These experiences gave me a perspective on regulated product development that most consultants simply don’t have.
But what drives me isn’t the credentials. It’s the work itself.
I am genuinely passionate about the industries I serve, the people building devices that help patients move again, see again, breathe again, live longer and better lives. That passion is what gets me out of bed in the morning and what I bring to every engagement. When you work with QMC, you’re not getting a consultant who checks boxes, you’re getting someone who cares deeply about your program succeeding because the products we build together matter.
I work with clients across the US and internationally. I hold a PMP certification and dual bachelor’s degrees in Biomedical Engineering and Physics.
If you’re building something that matters, I’d love to be part of it.
Contact
Let’s Connect
If you’re building something that matters, I’d love to be part of it.