Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity episode artwork

EPISODE · Apr 15, 2025 · 38 MIN

Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity

from Project Medtech · host Project Medtech

In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role of thorough market research in achieving success. Tune in for valuable insights on building compliant, secure, and market-ready medical devices.Niki Caporali Spaniel LinkedIn Chad Gibson LinkedInCMD Website⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

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Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity

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