In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect.
The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors.
In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world.
Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it s a requirement or a tool to help achieve compliance. The Lessons from the Road icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
James B. Shore is Director of Quality at Titan Medical Inc. He has more than 25 years of quality and supplier management experience working in medical devices, semiconductor, aerospace, and Department of Defense (DoD). He holds a BS in Industrial Technology from the University of Lowell, an MS in Management from the Lesley School of Management, and a graduate certificate in Health Products Regulations from Regis College. Shore is a senior member of ASQ and a Certified Six Sigma Black Belt (CSSBB), Manger of Quality/Organizational Excellence (CMQ/OE), Biomedical Auditor (CBA), and Quality Auditor (CQA). He is also a United States Marine Corps veteran.
John A. Freije is Principal Consultant at Freije Quality Engineering, LLC, where he works with medical device companies and suppliers to medical device companies to develop and implement quality systems that exceed the expectation of ISO 13485 and the FDA s Quality System Regulation 21 CFR 820. Previously, he held several positions at Roche Diagnostics, Eli Lilly & Co., Raytheon Technical Services, and the US Army. Freije holds a BS in MET from Purdue University and an MSE in MEPP from the University of Wisconsin-Madison. He is a senior member of ASQ and a Certified Quality Engineer (CQE).
