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For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.Some of the highlights of this episode include:The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.The Design History File (DHF), Device Master Recor