MedTech Expertise You Can Trust

End-to-end regulatory, quality, and clinical research services — built to help medical device teams move faster and reduce risk.

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Medical Device Consulting Services

Full lifecycle support. One partner.

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Regulatory Consulting

  • 510(k), PMA, and De Novo submission support
  • Global regulatory strategy and market access
  • Post-market compliance and change control
  • Complaint reporting and daily regulatory tasks
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Quality Systems

  • QMS design, build, and implementation
  • ISO 13485 and 21 CFR Part 820 compliance
  • Fractional quality staffing and ongoing management
  • Remediation for warning letters and audit findings
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Clinical Research (CRO)

  • Pilot, feasibility, and pivotal trial management
  • Study design, site coordination, monitoring
  • Post-market clinical follow-up (PMCF)
  • Regulatory-ready data and reporting
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Design & Prototyping

  • Concept development and industrial design
  • Prototyping and design iteration
  • Design controls and DHF documentation
  • Pre-submission strategy and design reviews
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Wherever you are in your medical device development

We meet You where you Are.
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How We Work

Practical execution, not just strategy decks.

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Flexible Support

Need fractional regulatory support? Surge capacity for an audit? We scale with you—no long-term commitments required.

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Hands-On Execution

We don't just advise—we write submissions, build QMS documentation, manage studies, and deliver what you need to move forward.

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Integrated Planning

We build a roadmap that connects regulatory, quality, and clinical milestones. One timeline. One strategy. No vendor juggling.

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Discovery & Gap Analysis

We assess where you are, where you need to be, and what's actually blocking progress. No 50-page reports—just clear next steps.

Testimonials

What Our Clients Say

“The team at Prime Path Medtech consistently goes above and beyond, whether implementing quality systems or preparing critical submissions. Their attention to detail gave us confidence in every step. They are not only experts, but also trusted allies whose determination makes us feel fully supported as we grow."
CEO, Serena Sleep Solutions
Gary Maas
“Prime Path Medtech brings a unique combination of technical expertise and business insight, helping us refine our regulatory strategy while keeping our broader objectives at the forefront. Their practical and timely guidance saved us both time and resources. Their ability to balance precision with speed is unmatched and what sets them apart.”
CEO, ParaNano Wound Care
Chelsea Luxen
“What stood out most to us was how seamlessly Prime Path Medtech integrated with our team, taking ownership of the details from protocol development to patient enrollment, so we could stay focused on our product. It felt like gaining an extension of our own staff, and that level of commitment is exactly what makes them such a valuable partner in clinical research.”
CEO, Uromedica
Tim Cook
Medical Device Insights

Medical Device Insights

Practical, plain-English guides written for lean device teams.

View all resources
Regulatory

A Complete Guide to Classifying Your Medical Device for FDA Approval

Correctly classifying your medical device is key to a smooth FDA approval process. Choosing the right classification at the start of the process helps streamline regulatory requirements

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Quality

How to Create an Effective Quality Management System (QMS) for Medical Devices

In the medical device industry, ensuring product safety, effectiveness, and compliance with regulatory standards is paramount.

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Regulatory

How To Choose A Predicate Device

A 510(k) is a marketing submission to the FDA made by a manufacturer to demonstrate that a new device is substantially equivalent to an existing "predicate device."

Read article →

Ready to move your device forward?

Whether you're planning your first 510(k) or scaling to commercialization, let's talk about what you actually need.

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