Medical Device Regulatory Strategy
The regulatory strategy your medical device actually needs
Startups can’t afford regulatory mistakes. As a medical device regulatory consultant with 30+ years of FDA, CE mark, and clinical trial expertise, Lucent Clinical Consulting LLC delivers senior-level strategy to the companies that need it most — without the Fortune 200 price tag.
$570K saved – CE mark strategy
<1 year to FDA De Novo granted
$1M+ clinical trial cost reduction
Three 510(k) clearances for one client
What a medical device regulatory consultant delivers:
$570K
Saved in development costs by justifying broad CE Mark claims for a novel cardiovascular diagnostic assay for a pharmaceutical client – without compromising regulatory defensibility. Delivered results six month faster than planned.
<1 Year
FDA De Novo granted for an AI/ML cardiac rhythm detection algorithm with Breakthrough Device Designation.
$1M+
Reduction in clinical trial monitoring lifetime costs through risk-based methodology — for a diagnostic device client that couldn’t afford to cut corners on quality.
Full-lifecycle medical device regulatory consulting
From business case to post-market surveillance — Lucent Clinical Consulting LLC covers every stage of your device's regulatory and clinical journey.
01
Business Case
02
Feasibility & Design
03
Verify Design
04
Clinical Validation
05
Market Release
06
Sustain Market
Built for how regulatory and clinical trial work actually gets done.
Lucent SRD™ System · Regulatory Workflow Tools · Trademark Pending
Created by someone who has done this work for 30 years.
Coming Soon! The Lucent SRD™ System is a suite of scalable workflow tools for regulatory, research, quality, HEOR and clinical professionals. Not generic templates scraped from the internet — purpose-built instruments that mirror how clinical protocol submissions actually work.
Saves time. Increases quality. Promotes compliance.
- Structured regulatory document templates that standardize the study risk determination process
- Compliance-ready audit frameworks that consider QMSR requirements
- Early planning tools to strategically assess clinical study risk before the protocol is finalized
- Tools and guides for Sponsors
- Tools and guides for Institutional Review Boards
What Clients Say:
“Kimberly turned what initially looked like a failed 510(k) submission into three successful 510(k) clearances. I don’t know where we’d be without her expertise and attention to detail.”
CEO · AI Medical Imaging Startup · Confidential
“We achieved Breakthrough Device Designation. Kimberly knew exactly how to position us with the FDA and answer all of their questions.”
Co-Founder · Digital Health Company · Confidential
Your device deserves a strategy, not a guess.
Let’s figure out where you are and what you actually need. No sales pitch. No retainer required to start.