Medical Device Regulatory Practices

This book is intended to serve as a reference for professionals in the medical device industry, in particular 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. In today’s competitive environment, a few months’ delay in time to market can cost millions of dollars in missed opportunities. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book turns this concept around and 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: design and development, clinical evaluation, regulatory submissions and approvals, production, change management, and obsolescence. The reason behind choosing such a structure is that in reality this is how regulatory knowledge is used and applied in a medical device company.