We are a team of experts with over 20 years of experience in Medical Device Regulatory, Quality, and Clinical
About Lumen
Lumen Consulting (previously MedEdge Consulting) lights the way through the complex world of MedTech regulations. Our expertise and personalized approach make your path to FD and CE mark approvals faster, easier, and clear.
We break down every step, guiding your innovation smoothly from development to market. With Lumen, you can move forward confidently, know the journey to approval is as seamless as possible.
Fast Track Your MedTech Innovation
From preparing your first FDA submission to designing pivotal clinical trials and building audit-ready QMS systems, we serve as a steady guide and an extension of your team.
We’re here to make the hard things clearer — and the right path, lighter.
We believe innovators shouldn’t have to navigate regulatory uncertainty alone.
Why We Exist
Naz’s path from leading FDA submissions to partnering closely with startups led her to found Lumen Consulting, a boutique firm providing regulatory, clinical, and quality expertise to medical device and digital health innovators.
Naz is a regulatory strategist with over 20 years of experience helping medical device and digital health technologies reach the market. In 2017, she led the first FDA clearance for a machine learning, cloud-based imaging device, before clear guidelines for AI/ML even existed.
Since then, Naz has supported over 80 companies, cleared more than 40 submissions, and helped secure multiple Breakthrough Device Designations. She’s also taught regulatory sciences at Stanford, mentored founders through the CancerX Accelerator, and contributed to early FDA guidance around AI regulation.
Naz lives in Northern California, where she spends her time photographing nature, reading, and writing short stories that explore beauty, meaning, and change.
If you are building something meaningful in healthcare, she would be honored to help bring it to life.
Her superpower?
Making the complex feel doable, with CARE, CLARITY, and a sense of ownership.
Golnaz Moeini (Naz)
Meet the founder
We bring both to every engagement because that’s what meaningful progress requires.
The best work blends
strategy and heart
We make the path simpler, without sacrificing rigor.
Compliance shouldn’t
be Overwhelming
We’re invested in your mission and show up like we’re part of your team.
You Deserve a Partner,
not a Vendor.
What We Believe
Daniel
“Thanks for all your help, advice, and wisdom. I appreciate your guidance on this adventure.”
