This white paper discusses how artificial intelligence can support risk management activities within ISO 13485 and ISO 14971 environments, including complaint analysis, CAPA trending, post-market surveillance, quality system monitoring, and identification of potential risk signals. The paper emphasizes the importance of maintaining appropriate human oversight, documented rationale, and quality system controls when using AI-enabled tools in regulated medical technology environments.

What the paper covers

• How AI can support risk identification and trend detection
• Opportunities for improving complaint, CAPA, and post-market surveillance analysis
• Considerations for using AI within ISO 13485 quality system processes
• Alignment with ISO 14971 risk management expectations
• Practical guardrails for maintaining human review, traceability, and regulatory confidence

Who it is for

This paper is intended for regulatory affairs, quality assurance, risk management, post-market surveillance, and medical device leadership teams evaluating how AI may be used responsibly within regulated quality and risk management processes.