This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition.
About the Author: Nancy Van Schooenderwoert is President and Principal Coach at Lean-Agile Partners. Nancy was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. She has led Agile change initiatives beyond software development in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods. Initially working as an electronics designer and software engineer in flight simulation, she later focused on software engineering. Nancy has worked coaching Agile teams in the USA, UK, and Germany. Her coaching extended to their work with their teams in Japan, India, China and other countries. Nancy's experience spans embedded software and hardware development for applications in aerospace, factory automation, medical devices, defense systems, and financial services. Her coaching practice spans delivery teams to middle and upper managers. She is a regular presenter at Agile-related conferences worldwide. She is a founder and past president of Greater Boston's premier Agile user group, Agile New England. Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including Agile methodology), and evaluated 21 CFR Part 11 compliance. Brian's strengths include: - Application of software development lifecycle and quality systems in FDA-regulated environment. - Direct experience applying Electronic Records and Signatures rule (21 CFR Part 11) - Multidisciplinary team leadership: coordinating work, obtaining consensus, managing by influence - Applied knowledge of quality system components, SOP design, and auditing. Much of Brian's activity has been in validation and software quality for medical devices, but some of his projects have been for companies in clinical trial data managements. His clients have been in fields as diverse as medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.