AI-Automated FDA-Regulated Software Development
Supercharge FDA-regulated software development with AI automation, encompassing requirements gathering, software design, traceable documentation, verification, and validation—while meeting 21 CFR Part 820, IEC 62304, and HIPAA standards, assuring compliance by a human-in-the-loop approach.
Key Features
Our platform combines the power of AI with regulatory expertise to streamline the development of FDA-compliant software.
AI-Generated Code
Generate compliant code with built-in regulatory guardrails and best practices for medical device software.
Automated Documentation
Automatically generate comprehensive documentation that meets FDA requirements and standards.
Automated Testing
Automate unit test creation and execution, test protocols and automated UI testing for comprehensive verification.
Continuous Compliance Verification
Ongoing verification against FDA standards, including 21 CFR Part 820, IEC 62304, and HIPAA requirements.
Risk Management & Tracing
AI-powered tracking of risks, design inputs and outputs in compliance with ISO 14971, ensuring complete traceability.
Requirements Management
AI-assisted requirements gathering and management with traceability throughout the development lifecycle.
How It Works
RegFlow AI transforms the development process for FDA-regulated software.
Define Requirements
Specify your medical device software requirements using natural language or structured inputs.
AI Generation
Our AI orchestrates the creation of code, documentation, and tests that adhere to FDA standards.
Review & Validate
Validate the automagically generated artifacts and make any necessary adjustments before approval.
Approve & Deploy
Commit the validated changes and deploy with confidence, knowing all regulatory requirements are met.
Join the Waitlist
Be among the first to experience the future of FDA-regulated software development.