Program Management Leadership in Software based Medical Devices

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.

Autorentext

O currículo de Saleha Amin destaca mais de 15 anos de liderança em gestão de programas/produtos no âmbito da FDA, cuidados de saúde da UE, dispositivos médicos, biotecnologia e TI. Especialista em metodologias Agile, conformidade regulamentar para dispositivos médicos (Classe I-III) e aplicações de saúde digital. Defensor convicto das Metodologias Ágeis em ambientes regulamentados.