Hardware Podcasts

Quality Myths and Lessons Learned

Global Medical Device Podcast · 19 Jan 2023 · 45m · Episode 301

What this episode covers

Kevin Becker, author of 'Quality Myths and Lessons Learned' and Director of Quality at a med device component manufacturer, discusses common pitfalls in medical device quality engineering. He explains how misaligned incentives can lead to unethical behavior, such as falsifying data or hiding defects during FDA audits, and emphasizes the need for principle-based decision-making to overcome peer pressure and 'normalization of deviance.' Becker argues that management support is the most critical component of a Quality Management System (QMS) and shares lessons on statistical misconceptions, effective flowcharting, and the importance of integrity in engineering.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Hutchinson Technology
Also
ASQ, FDA, ISO 13485

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