FDA Approval Consulting for AI-Enabled Medical Device Software

Wellesley Cove Group (WCG) provides expert consulting services to AI companies navigating the complex FDA approval process for AI-enabled medical device software. With a deep understanding of regulatory frameworks and industry best practices, we help organizations accelerate compliance while maintaining innovation.

Our Services:

• Regulatory Strategy & Compliance: Guidance on FDA pathways (510(k), De Novo, PMA) for AI-based medical devices.

• Pre-Submission Support: Assisting in Q-submissions and interactions with the FDA to align on requirements early.

• Clinical & Data Validation: Ensuring AI models meet regulatory standards for safety, effectiveness, and real-world performance.

• Software as a Medical Device (SaMD) Compliance: Navigating FDA’s AI/ML regulations and Good Machine Learning Practices (GMLP).

• Post-Market Monitoring & Adaptive AI Compliance: Supporting AI model updates while staying within regulatory guidelines.

With the growing demand for FDA-approved AI technologies, WCG ensures AI innovators can bring their solutions to market efficiently while meeting all compliance requirements.

To learn more or discuss how we can support your FDA approval journey, contact us today.