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Home > Medical Device made Easy Podcast > The good, bad and uglyof using AIfor QA RA Compliance
Podcast: Medical Device made Easy Podcast
Episode:

The good, bad and uglyof using AIfor QA RA Compliance
Category: Business
Duration: 00:00:00
Publish Date: 2025-08-28 00:00:00
Description:
miniature episode 351 The Good, Bad & Ugly of Using AI for QA/RA Compliance RJ kedziora monir EL Azzouzi easy medical device

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

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