Accelerating FDA 510(k) Clearance for AI Software

Overview

A Seoul-based AI imaging startup faced a common hurdle: their innovative algorithm was ready, but their documentation was not. They were targeting FDA 510(k) clearance but were overwhelmed by the cybersecurity and software validation requirements.

The Challenge

• Complex Documentation: Over 3,000 pages of required technical files.
• Language Barrier: Translating technical nuance from Korean to FDA-compliant English.
• New Guidance: The FDA had just released new draft guidance on AI/ML change control.

The Solution

Leanabl stepped in with our Live Link Tech File system.

1. Gap Analysis: We identified missing cybersecurity controls in 48 hours.
2. Automated Formatting: Using Smart Formatter, we converted their raw engineering logs into submission-ready reports.
3. Strategic Review: We structured their predicate device comparison to preemptively address reviewer questions.

Results

• Clearance in 90 Days: Received 510(k) clearance with only one minor round of questions.
• Cost Savings: Reduced external consulting fees by 60%.
• Market Entry: Successfully launched in the US market 3 months ahead of schedule.