Greenfield Consulting, LLC partners with medical device companies to build quality systems, prepare regulatory submissions, and chart a clear path to market, all without the big-firm price tag.
From your first regulatory question to your first commercial shipment, and everything in between.
Determine the right pathway for your device, whether 510(k), De Novo, PMA, or Exempt, and build a submission strategy designed to clear FDA review efficiently.
Build a right-sized QMS that satisfies 21 CFR Part 820 and ISO 13485 requirements without burying your team in paperwork. SOPs, work instructions, and training that actually fit your operation.
Implement robust design controls from the start: user needs, design inputs and outputs, verification, validation, and a complete Device History File that stands up to audit.
Prepare for external audits with confidence. I'll assess your current QMS against regulatory requirements, identify gaps, and help you close them before a Notified Body or FDA inspector shows up.
Navigate the EU Medical Device Regulation and prepare the technical documentation your Notified Body needs, from clinical evaluation to post-market clinical follow-up.
Keep your device on the market and your patients safe. I'll set up complaint handling, MDR reporting, post-market surveillance plans, and periodic safety update reports.
A product that could genuinely improve patient outcomes, but the regulatory path ahead feels uncertain.
Classification, device type, applicable standards, and a clear timeline from concept to clearance.
QMS, design controls, risk management; practical systems that grow with your company.
Your device is cleared. Patients benefit. You grow with the compliance foundation to sustain it.
Whether you're a startup, a small team or, a large manufacture facing bandwidth limitations, Greenfield was made for you.
Overwhelmed by regulatory requirements? I translate regulations into plain language and actionable steps your team can follow.
Can't afford a full-time RA/QA team? Get senior-level expertise on a flexible, project-based model, all without the full-time overhead.
Facing your first FDA submission? I guide you through the entire 510(k) process: predicate research, technical sections, and handling deficiencies.
Worried about your next audit? I conduct gap assessments and mock audits so you walk in prepared, not reactive.
No jargon. No surprises. Just a clear plan from our first call to your cleared device.
We talk through your device, where you are in development, and what's standing between you and market clearance.
I deliver a clear, written strategy outlining your regulatory pathway, key milestones, timelines, and what to expect.
We work together. I build documents, review submissions, and advise your team with direct, responsive communication.
You receive your clearance. I help you set up post-market systems so you can grow without compliance surprises.
Working with Greenfield means you get a single, experienced point of contact, not a rotating cast of junior consultants.
Every email, call, and deliverable comes from me personally. Your questions get answered by the person doing the work, not a project manager relaying messages.
I don't just handover an out-of-the box QMS systems designed for 500-person enterprises to each client. Everything I deliver is scaled to your team size, your budget, and your actual risk.
I know investor milestones and product launches don't wait. I structure my work around your timelines and communicate proactively if anything shifts.
Regulations are complex. My explanations aren't. I translate the CFR and ISO standards into practical guidance your whole team can act on.
"My goal isn't just to check compliance boxes, it's to give your team the clarity and confidence to make good decisions and bring safe, effective devices to the patients who need them."
Let's start with a free 30-minute call to map out your regulatory path and see how I can help.