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Smarter Design Controls with AI - Is It Possible?
Manage episode 520448846 series 3428201
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Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.
In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards.
Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.
Topics Include:
- What design controls are and why they matter for medical devices and combination products.
- How AI is evolving from a personal tool to a professional asset in regulated environments.
- Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.
- Specific uses within Design Verification, including sample size determination and data analysis.
- Managing AI risks: why "hallucinations" happen and the need for expert human oversight.
- Sustainability considerations: could AI use impact environmental goals in MedTech?
Whether you’re a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.
📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.
#MedTech #AI #DesignControls #MedicalDevices #RegulatoryScience #LifeSciences
40 bölüm
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