Program Management Leadership in Software based Medical Devices - Amin, Saleha
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The book serves as a comprehensive manual for mastering program management leadership within the realms of medical devices and healthcare in FDA and OUS environments. It intricately stitches together the fabric of strategic leadership, the intricacies of navigating the regulatory mazes, the groundwork for initiating impactful healthcare projects, the meticulous process of requirement analysis, the art and science behind design and development, the non-negotiable standards of quality assurance, the foresightedness required in risk management, the orchestration of supply chain logistics, and the…mehr

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Produktbeschreibung
The book serves as a comprehensive manual for mastering program management leadership within the realms of medical devices and healthcare in FDA and OUS environments. It intricately stitches together the fabric of strategic leadership, the intricacies of navigating the regulatory mazes, the groundwork for initiating impactful healthcare projects, the meticulous process of requirement analysis, the art and science behind design and development, the non-negotiable standards of quality assurance, the foresightedness required in risk management, the orchestration of supply chain logistics, and the criticality of exhaustive testing and verification protocols. At its core, the narrative champions the cultivation of a strategic vision, the art of resource orchestration, the power of stakeholder engagement, unwavering adherence to regulatory dictums, and an unyielding commitment to quality and compliance as the keystones for the successful realization of healthcare programs and the launch of groundbreaking medical devices. This book serves as a beacon for aspiring leaders looking to make a tangible impact in the world of healthcare and medical device innovation.
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Autorenporträt
Saleha Amin's resume highlights 15+ years of leadership in program /product management within FDA, EU healthcare, medical devices, biotechnology, and IT. Expert in Agile methodologies, regulatory compliance for medical devices (Class I-III), and digital health applications. Staunch proponent of Agile Methodologies in regulated environments.