Hardware Podcasts

#352: Fundamentals of Quality & Regulatory

Global Medical Device Podcast · 18 Jan 2024 · 50m · Episode 352

What this episode covers

Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

Most relevant to

companies scaling up and large enterprises

Topics

Mentioned

Companies
JMT Compliance Consulting, Medtronic, Boston Scientific, Johnson & Johnson, Greenlight Guru, UC San Diego extension, FDA, GE healthcare, Nevro, American medical Systems, outset medical, Genzyme, Eastern Michigan University, University of Phoenix
Tools
Enneagram, DISC, Myers Brigg

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