ChatMD Quality Management System (QMS)

Ensuring High Standards in Digital Healthcare

ChatMD maintains a robust Quality Management System (QMS) to ensure the safety, reliability, and compliance of ChatMD as an FDA Class 1 medical device. Our QMS framework aligns with FDA, HIPAA, and FTC regulations to guarantee that ChatMD meets the highest standards in telemedicine software development, security, and patient care.

Key QMS Components

✔ Regulatory Compliance & Documentation – Full adherence to FDA Class 1 Software as a Medical Device (SaMD) regulations.
✔ Internal Audits & Performance Monitoring – Routine assessments to identify and correct potential compliance gaps.
✔ Risk Management & Safety Protocols – Comprehensive hazard analysis and risk mitigation strategies for safe device operation.
✔ Post-Market Surveillance & Continuous Improvement – Tracking user feedback, safety reports, and software performance for ongoing enhancements.

Quality Management Policies & Procedures

ChatMD’s QMS includes a detailed compliance framework that governs all aspects of ChatRx’s development and operation:

📜 ChatMD Quality Management System (QMS) Protocol and Procedure Plan
📜 ChatMD FDA Post-Market Surveillance Policy, Procedure, and Process

Commitment to Continuous Improvement

💡 ChatMD is dedicated to innovation, patient safety, and compliance. Our QMS ensures that ChatRx remains a reliable and trusted telemedicine platform while evolving with regulatory and industry advancements.

For questions regarding our Quality Management System, contact trust@chatrx.md