AI Tools in Quality and Regulatory

Overview:

AI Tools in Quality and Regulatory:
AI is increasingly used in quality and regulatory work, from gap analyses and document review to eQMS and technical documentation support. While these tools promise major efficiency gains, they also introduce new risks around correctness, oversight, and long-term regulatory expertise.

In this SaMD Meetup, Eric de Zeeuw from Tooling Studio will share how AI-driven gap analysis can speed up assessments against standards and regulations. Miguel Amador from Complear will share practical use cases of AI in the eQMS and technical documentation space, highlighting both efficiency gains and common risks in day-to-day QA/RA workflows. Leon Doorn from MedQAIR will then take a broader perspective, focusing on governance, oversight, and the long-term regulatory and compliance risks organizations must address when adopting AI tools.

Agenda:
Introduction (5–10 minutes):

• Welcome and overview of AI applications in Quality and Regulatory for SaMD.

Session 1 (30–40 minutes + Q&A):

• Eric de Zeeuw — AI-driven Gap Analysis
• How AI can speed up assessments against standards and regulations.

Session 2 (30–40 minutes + Q&A):

• Miguel Amador (Complear) — AI in eQMS & Tech Docs: Practical Applications and Pitfalls
• Where AI adds value, and where risks must be carefully managed.

Session 3 (30–40 minutes + Q&A):

• Leon Doorn — Governance and Regulatory Oversight for AI in QA/RA
• Key considerations for oversight, compliance, and sustainable regulatory expertise.

Conclusion (5 minutes):

• Wrap-up, key takeaways, and next steps.

Event Date & Time:
March 12th - 7:30 PM – 9:30 PM