Overview

Medical devices play a crucial role in healthcare, but their safety and effectiveness must be carefully managed to protect patients. This book explores the principles and practices of risk management in the medical device industry. It also covers hazard identification, risk assessment, regulatory compliance, and post-market surveillance, including real-world applications and challenges. The book is an indispensable resource for professionals in healthcare, biomedical engineering, and regulatory affairs.

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9781779564696

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Author Information

Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist's Sanctuary (www.scientistssanctuary.com) – a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.

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