MDF Batch record

AI-Powered eDHR & MDF Batch Record Software for FDA QMSR Compliance

Leucine ensures seamless compliance with FDA’s updated Quality Management System Regulation (21 CFR Part 820) and ISO 13485:2016. Our AI-powered Electronic Device History Record (eDHR) and Medical Device File (MDF) system automates compliance, streamlines audits, and accelerates product release.

Request a Demo

The First Predictive eDHR & MDF Batch Record System - Ensuring Compliance Before Issues Arise

Automate batch documentation, enhance traceability and eliminate inefficiencies for seamless compliance and operational excellence

Regulatory Compliance & Readiness

Fully aligned with ISO 13485:2016 and evolving FDA QMSR (Quality Management System Regulation), reducing risks and easing your transition to new regulatory standards.

End-to-End Traceability & Integrity

Automated audit trails, secure electronic signatures, and real-time validation provide complete batch visibility and robust data integrity.

Efficiency & Scalable Integration

Easily integrates with your existing QMS and ERP systems, reducing manual interventions, boosting accuracy, and ensuring a single source of truth for compliance data.

Real-Time Data Capture & Validation

Automatically log critical manufacturing parameters, operator verifications, and test results to maintain continuous traceability and immediate compliance checks.

AI-Powered Risk Management

Identify and mitigate compliance risks before they escalate

Built-in Compliance with 21 CFR Part 11 & ISO 13485

From secure electronic signatures and tamper-evident audit trails to controlled user access, fulfill FDA and ISO requirements for data integrity within a single integrated platform.

Seamless Integration with QMS & Supply Chain Systems

Connect with existing Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) solutions to create a unified, streamlined compliance ecosystem.

Frequently Asked Questions

Can I trial Webflow before paying?

Sure! You can test out Webflow on our free plan where you can experiment with 2 projects. Your unhosted projects will have a two-page limit, but you can purchase a site plan on a per-project basis to unlock up to 100 static pages and additional CMS pages.

What is a project?

A project is a website that you build in Webflow. You can publish projects to a webflow.io staging subdomain for free, export the code on a paid plan, or add a site plan to connect your custom domain and unlock hosting features.

What can I white label?

Pro accounts can add their own logo to Client Billing forms and the Editor. Pro accounts can also remove references to Webflow in the source code and form submission emails, and hide the Webflow badge from their staging sites.

Frequently Asked Questions

What is the Business Impact?

50% Reduction in batch record processing time
40% Improvement in compliance readiness
30% Faster audit preparation with automated reporting
100% Traceability across manufacturing operations

Who Benefits from this solution?

Medical Device Manufacturers (Class I, II, III)
Regulatory & Quality Teams ensuring ISO 13485 & FDA compliance
Operations & Manufacturing Leaders optimizing efficiency & traceability

How does Leucine simplify compliance with FDA’s QMSR?

Leucine automates risk management, documentation, and real-time monitoring—aligning with FDA QMSR and ISO 13485, reducing audit risks and manual effort.

Will Leucine integrate smoothly with our existing systems?

Yes. Leucine integrates seamlessly with leading QMS, ERP, and MES platforms, ensuring zero disruption to operations.

Can Leucine help with FDA submissions like eSTAR?

Absolutely. Leucine generates structured, compliant records to streamline eSTAR submissions, audits, and regulatory reporting.

Future-Proof Your Compliance with MDF Batch Records

Request Consultation

Stay ahead of regulatory changes with a smarter, ISO 13485- and FDA QMSR-aligned batch record management system. Get early access to next-gen eDHR solutions!