The good, bad and uglyof using AIfor QA RA Compliance

Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance?

In this new episode of the Medical Device Made Easy Podcast, Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of using AI in regulatory compliance. Together, they discuss:

Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok

How to integrate AI into different product design and regulatory phases

The role of Prompt Engineering and why it matters in compliance

Practical tips for creating effective AI prompts

The warnings and risks you should keep in mind when relying on AI

How agencies like the FDA are beginning to explore AI for dossier reviews

👉 If you want to stay ahead in the world of medical device compliance, this conversation is a must-li