At Lumen Consulting, we help medical device and digital health startups navigate the complex path to market. Whether you're preparing for your first regulatory submission, designing a pivotal clinical trial, or building a right-sized QMS, we bring both strategic insight and hands-on execution- so you can keep moving forward with confidence.
Helping innovators deliver life-changing technology- with clarity, strategy, and trust.
Who We Are
We design efficient, regulator-aligned studies, including pivotal trials, retrospective studies, and MRMC designs that generate the evidence your innovation deserves.
Clinical Study Design &
Evidence Planning
From scratch-built ISO 13485-aligned QMS to internal audits and cybersecurity risk assessments, we help you meet compliance requirements without overcomplicating your process.
Quality Systems &
Audit Readiness
We guide you through the FDA process (510(k), De Novo, Pre-submissions, Breakthrough Designation, STeP, and more) with the clarity and rigor needed to get your product to market.
Regulatory Strategy & FDA Submissions
We offer three core services designed to guide you through key milestones- from early development through clearance.
Strategic Services to Accelerate Your Path to Market
WHAT WE DO
We understand the pressure of building in healthcare, especially when you’re moving fast, raising funds, or working with a lean team. At Lumen, we act as an extension of your company. We bring clarity to the complex process, anticipate what’s ahead, and support you with the same care and commitment we’d want on our own team.
We’re not just consultants. We’re part of your team.
Why Lumen
Daniel
“Thanks for all your help, advice, and wisdom. I appreciate your guidance on this adventure.”
