Hardware Podcasts

#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

Global Medical Device Podcast · 5 Jan 2026 · 50m · Episode 440

What this episode covers

Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

Most relevant to

established companies

Topics

Mentioned

Companies
JMT Compliance Consulting, Medtronic, Boston Scientific, Greenlight Guru, UC San Diego Extension, FDA
Also
Steve Jobs

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