Click Here to Download: https://ouo.io/dKVQYI6 Medical Device Regulatory Practices An International Perspective By: Val Theisz Publisher: Jenny Stanford Publishing Print ISBN: 9789814669108, 9814669105 eText ISBN: 9789814669115, 9814669113 Edition: 1st Copyright year: 2015 Format: PDF Available from $ 23.18 USD SKU 9789814669115R90 This 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. Most 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 and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
