MEDILEXIS
Transforming Medical Device Compliance with AI
The Challenge
Medical device companies face unprecedented challenges in bringing their innovations to market:
- Complex regulatory standards across different regions
- Time-consuming documentation and compliance processes
- High costs of testing and meeting compliance requirements
- Significant risks from compliance errors, including potential recalls and reputational damage
With a single testing mistake potentially costing up to $50,000 and recalls impacting the industry by $5 billion annually, the stakes couldn't be higher.
Our Solution
MediLexis is an AI-driven compliance platform designed to streamline the complex regulatory processes that medical device companies face. We simplify compliance, reduce costly errors, and accelerate time-to-market, empowering companies to focus on what matters most—innovating life-saving technologies.
Platform Overview
MediLexis is designed as a comprehensive end-to-end compliance platform that's both user-friendly and highly automated. From intuitive navigation to seamless workflows, every element is crafted to simplify the complex regulatory process.
Key Features
Instant Risk Classification
Quickly identify your device's risk classification under EU and FDA regulations. Our AI system identifies possible predicate devices and delivers tailored results.
ISO Compliance Guidance
Navigate through relevant standards and testing processes efficiently, ensuring your device meets global requirements.
Cost & Timeline Estimation
Get accurate testing cost and timeline estimations based on your device's risk classification and regulatory needs.
AI-Powered Documentation
Generate drafts for critical regulatory documents, saving time and reducing the risk of errors.
Coming Soon
We're working on exciting new features to make regulatory compliance even more streamlined. Stay tuned for updates about our document management system and advanced automation capabilities.