Will Your Current Data Survive Scrutiny?
We stress-test your technical files against 10,000+ audit findings to expose Critical Gaps before the reviewer does.
Standards Check
Verify if you are using the latest harmonized standards (e.g., ISO 14971:2019) or withdrawn versions.
Clinical Diagnostics
Assess if your clinical data is sufficient for regulatory equivalence claims or if you need a new investigation.
Actionable Roadmap
We don't just say 'fail'. We provide a step-by-step remediation plan with estimated timelines and costs.
Why Leanabl for Gap Analysis?
Former Auditors
Our team includes former Notified Body reviewers who know exactly where to look for gaps.
AI-Accelerated
We use AI tools to scan your voluminous documentation faster, focusing human expertise on complex judgments.
Risk-Based Approach
We prioritize gaps by risk level (Major vs. Minor), so you know what to fix first.
The Assessment Workflow
Data Intake
We collect your current Technical File, DHF, and Quality Manual via our secure portal.
Deep Dive Review
Our experts cross-reference your data against the specific targeted regulation (e.g., ISO, IMDRF).
Report & Workshop
We present a detailed dashboard of Red/Yellow/Green areas and host a strategy workshop.
What You Get
Frequently Asked Questions
How long does it take?
Typically 2 weeks for a standard Class IIa/IIb device.
Do you fix the gaps?
We can. After the analysis, you can hire us to implement the fixes or do it yourself.
Is it confidential?
Absolutely. We sign an NDA before receiving any data.