The Cost of 'Refuse to Accept'
A submission is not just a data dump. Poorly organized technical files lead to immediate rejections (RTA) or endless, costly cycles of 'Additional Information' (AI) requests from regulators.
Narrative Disconnect
Engineering test data that doesn't clearly support the proposed clinical indications for use, creating confusion for the reviewer.
Incomplete Traceability
Failure to create a clear, auditable trail linking user needs, design inputs, risk controls (ISO 14971), and verification testing results.
Administrative Errors
Simple but critical mistakes in formatting, file naming, or missing signatures that trigger immediate bureaucratic rejections.
The Leanabl Insight
We view a submission as a 'Safety Story'. We construct a compelling, logical narrative that makes it easy for the reviewer to understand the device and say 'Yes'.
Turnkey Submission Management
We act as your bridge to global markets, with specialized native expertise in Korea and comprehensive capabilities for the US and EU.
Korea MFDS (K-FDA) Specialization
- Native Expertise: The fluency and nuance of a local partner.
- Technical Translation: STED and submission document localization.
- KGMP Support: Guidance through Korea Good Manufacturing Practice certification.
US FDA 510(k) & De Novo
- Full Drafting: Management of all 20+ sections of a traditional 510(k).
- eSTAR Management: Expertise in the FDA's interactive PDF submission template.
- Equivalence Strategy: Crafting a compelling 'Substantial Equivalence' argument.
EU MDR/IVDR Technical Files
- Annex II & III Compilation: Structuring your Technical Documentation for Notified Bodies.
- GSPR Checklist: Systematically demonstrating compliance with General Safety & Performance Requirements.
- Notified Body Coordination: Acting as your liaison during the review and audit process.
From Gap Analysis to Approval
We act as your regulatory front-line, shielding your R&D team from administrative burden so they can focus on innovation.
Readiness Review
A forensic gap analysis of your existing documentation to identify missing data before we write a single word.
Narrative Construction
We write, compile, and format your entire submission package, translating complex engineering data into a clear regulatory story.
Agency Defense
We manage all communication with the regulatory body, including drafting responses to Additional Information (AI) requests.
Your Final Deliverables
Submission-Ready Package (MFDS, eCopy, eStar)
Executive Summary for Stakeholders
Deficiency Response Strategy
Why Trust Us With Your Clearance?
Korea-First Capability
Unlike generalist consultancies, we possess unrivaled depth in the Korean market, offering a direct and efficient gateway to the broader Asian market.
Zero RTA Focus
We aim for zero 'Refuse to Accept' decisions by rigorously validating submission completeness and administrative accuracy before it goes out the door.
Global Parallel Processing
We leverage a unified data-first approach, enabling us to prepare Korean, US, and EU submissions simultaneously to minimize waste and redundant work.
Get Cleared. Get to Market.
Don't let paperwork delay your launch. Let us build a submission that gets approved.
Discuss My Submission Needs