Ambiguity is the Enemy of Speed
In MedTech development, choosing the wrong regulatory path is the costliest form of 'Waste' (Muda). It doesn’t just delay your launch; it drains your budget on activities that add no value and can even set your submission back.
Over-Classification
Assuming a higher risk class than necessary, leading to excessive, costly, and time-consuming clinical data requirements.
Predicate Traps
Selecting a 510(k) predicate device that is technically similar but legally obsolete or recalled, triggering additional data requests.
Testing Mismatch
Conducting expensive clinical or non-clinical tests that the target regulator doesn't require, or worse, that raise new questions.
The Leanabl Insight
We treat Regulatory Strategy as a critical Design Input. By defining the optimal pathway at the start of the development process, we eliminate costly rework, streamline testing, and create a predictable timeline for investors and stakeholders.
Strategic Roadmap, Not Just Rule Interpretation
We analyze your technology against current regulations to engineer the most efficient path to approval.
Classification & Pathway Confirmation
We provide a definitive risk classification for your device across key markets (FDA, MDR, MFDS) to determine the required submission type (e.g., 510(k), De Novo, CE Mark).
Predicate & Clinical Strategy
Our team strategically selects predicate devices and defines the minimal clinical evidence needed, preventing over-investment in unnecessary trials.
Data Gap Analysis
We map your existing evidence against regulatory requirements to identify what testing is truly required ("Missing Tests") versus what is assumed ("Unnecessary Tests").
Specialized Focus: Korea (MFDS)
We leverage deep, native expertise to navigate the unique requirements of the Korean market, a crucial and often complex gateway to Asia.
Structured Engagement for Clear Results
We don't leave you with a 100-page law textbook. We give you a navigation system.
Discovery Workshop
A 60-min virtual meeting to align on your device, goals, and target markets.
Strategy Development
2-3 weeks of internal analysis by our regulatory and commercial experts.
The Roadmap Handover
A final report and executive presentation detailing the optimal path forward.
Your Final Deliverables
Regulatory Strategy Report
Submission Timeline
Pre-Submission Questions
Why Choose Leanabl RegPath?
Business-Aligned
We look for the ‘fastest’ path that still supports your essential commercial and marketing claims, ensuring regulatory efforts drive business value.
Integrated R&D
We speak the language of engineers. We translate complex regulations into clear design inputs and testing requirements for your technical team.
Korean Market Access
We possess an unrivaled, specialized capability to unlock the lucrative and complex South Korean market, a key APAC gateway.
Ready to execute the plan?
Define Your Path. Accelerate Your Launch.
Stop guessing. Get a definitive regulatory roadmap tailored to your device.
Start My Regulatory Assessment