Medical Device Regulatory Practices by Val Theisz - 9789814669108

Jenny Stanford Publishing

Medical Device Regulatory PracticesAn International Perspective\nAuthor(s): Val Theisz\nFormat: Hardback\nPublisher: Pan Stanford Publishing Pte Ltd, Singapore\nImprint: Pan Stanford Publishing Pte Ltd\nISBN-13: 9789814669108, 978-9814669108\nSynopsis\nThis book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. \n\nMost books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems .