Medical Device made Easy Podcast
• 35 min
The good, bad and uglyof using AIfor QA RA Compliance
About This Podcast
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
RJ Kedziora
Co-Founder/COO Estenda Solutions
The host serves as co-founder of Estenda Solutions and focuses on people and process management and provides strategic technical direction, guidance, and innovative insights creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient/provider satisfaction.
