Global regulatory guidance. Built around you
Building regulatory strategy: Don’t let compliance be an afterthought
Your device is almost ready. The business team’s chasing leads while you’re eyeing revenue. But without a smart regulatory strategy in place? That’s like starting out on a world tour without an itinerary! At LucidMind Consulting, we help you map the right regulatory route — one that aligns with your device’s complexity, regulatory landscape and your market ambitions. We make compliance part of your go-to-market strategy, not an obstacle to it. You’ll be surprised at the number of companies who wish they’d done this sooner!
Early Strategy Saves Time
Planning your regulatory approach from day one prevents costly pivots and delays later in development.
Global Market Access
Understanding international requirements early opens doors to multiple markets simultaneously.
Faster Time to Market
Strategic planning reduces regulatory review cycles and accelerates your path to commercialization.
Global Approval Pathways
From the USFDA to the EU MDR, Health Canada, UKCA, CDSCO, and more, our strategies are meticulously crafted with a global perspective. We provide comprehensive support to guide you through approval processes across significant markets, including the United States, the European Union, Canada, the United Kingdom, the Middle East, India, ASEAN countries, and others. Our tailored and market-specific assistance ensures a seamless and efficient regulatory journey.
US FDA
510(k)
EU MDR (Class IIA)
CE marking, notified body approval
CDSCO (Class C, D)
Import license, clinical trials
Health Canada (class II)
Medical device license
We’re the Go-Getters in your corner
With years of hands-on regulatory experience, we embed ourselves in your team and do the heavy lifting — so you don’t have to.
From Scalpel to Software — We Handle It All
Whether it’s a traditional device, an AI-powered software (SaMD), or a wearable like a smartwatch that tracks health conditions, we’ve got your back. We’ll build your regulatory strategy, prep all your docs, and handle the back-and-forth with authorities so you don’t have to.
No jargon, no black box — just clear, actionable steps. Because compliance shouldn’t be a bottleneck — it should be your launchpad.
Collaborative Execution for Dossier Developmen
From 510(k), De Novo, Breakthrough designation, Tech file, and CER to Cybersecurity, IEC 62304, IEC 62366 documents and more; we prepare every required document with precision. – We don’t just advise. We partner. Your goals become our mission.
Pragmatic, No-Fluff Approach
Inspired by the FDA’s “least burdensome” principle, we aim for smart submissions, not bloated ones. This ensures that the approval lead times are minimized, predictable, and aligned with your go-to-market strategy.
Tailored to your needs
Whether you need comprehensive support or targeted expertise, we have the right solution for you. Whether you’re a manufacturer who needs complete end to end assistance, last-mile support or assistance with just a Presub/Qsub, we’re there for you to ensure you only pay for what you need.
Your journey to market
From initial concept to market approval, we guide you through every critical milestone.
Idea
Innovation concept
Strategy
Regulatory pathway
Dossier
Documentation prep
Approval
Market entry
Cut through the regulatory noise
Book a free consultation to discuss your regulatory pathway and get expert guidance tailored to your device.
Book a Free Consultation