Global Medical Device Podcast Powered By Greenlight.guru

This episode takes an unexpected journey with Edwin Bills, a lead expert in medical device risk management and a key contributor to the development of ISO 14971. Edwin shares stories from his diverse career, beginning with his time as a submariner and electronics technician in the Navy, where he worked on early GPS technology and helped build missile subs from the ground up. This unique hands-on experience taught him the importance of knowing every component of a system.From there, Edwin transitioned into manufacturing, where he applied his skills in teaching electronics and later, quality management. He was trained by renowned quality gurus like Joseph Juran and learned about concepts like Six Sigma and Kaizen from companies like Motorola and Toyota. These experiences, which focused on process improvement, cost of quality, and efficiency, laid a critical foundation for his future work.Edwin connects these seemingly disparate experiences to his pivotal role in medical device risk management. He explains how i