Medical Device Regulatory Practices - An International Perspective
by Val Theisz
Hardback 570 pages 2015-07-31 Print ISBN: 9789814669108 eBook ISBN: 9789814669115 DOI: 10.4032/9789814669115
List price : $149.95
“This is a monumental volume in which Theisz has left no stone unturned in the regulatory scene for medical devices. In its depth it addresses regulatory requirements throughout the device life-cycle. In its breadth it covers every key regulatory regime across the globe. Forged in the crucible of hands-on experience, it is a ‘must-have’ reference for every regulatory professional, from novice to expert. Every office should have one.”
Rod Ruston, FRAPS - Consultant with 30 years in regulatory affairs
“A masterful and eloquent presentation of the highly complex regulatory environmental factors for medical device design and development, Medical Device Regulatory Practices provides essential knowledge required to enable company boards, executives and product development project teams to successfully develop and seek regulatory approval for their medical device.
“For practitioners in the field of medical device design, development and regulatory approval, this book provides information which enables the communication gap between novice and experienced team members to be painlessly bridged and also serves as an indispensable day to day reference.
“It comprehensively presents important medical device industry–specific knowledge with depth, precision, clarity and accuracy.
“By providing historical context about the regulations, this book promotes empathetic alignment with the need for compliance, through an understanding of the development of global medical device guiding principles.
“The book walks the reader through the medical device pre- and post-market processes, introducing essential terminology with each subject discussed. Case studies provide thoughtful examples of experiences gained and shared among colleagues who are contributing to the health of people around the entire globe.”
Steve Marshall - CEO, Perficio Product Development, Australia
“I can only commend Val's book to all newcomers in the regulatory profession, be it in industry or in a regulatory agency. It explains the basics very well also for a start-up or an inventor who has to start dealing with regulations if he or she ever wants to market a product. I'm sure it could also be used as a valuable tool for those departments or ministries of health that want to set up a new national medical device regulatory agency in their jurisdictions. As it gives a global overview of how regulatory systems are applied in different legal settings and how industry should deal with these requirements, it is a unique guidance reference book for medical device regulations. Using the information contained in this book will make life easier for regulatory affairs professionals.”
Rainer Voelksen - Project Manager, Swiss Federal Office of Public Health
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, 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.
About the Editor:
Val Theisz is a regulatory professional with over 15 years’ experience in medical device regulations, of which he spent eight years in leadership roles in regulatory affairs, regulatory operations, and quality assurance. She holds a masters degree in electrical engineering from the Polytechnic University of Timi?oara, Romania, and Regulatory Affairs Certification (RAC) for European and US regulations from the Regulatory Affairs Professionals Society (RAPS). Val has been a RAPS Fellow since 2010.
|1||Chapter 1: Overview of the International Regulatory Framework for Medical Devices|
|89||Chapter 2: Safety and Effectiveness|
|173||Chapter 3: Technical Documentation|
|241||Chapter 4: Pre-Market Phase|
|319||Chapter 5: Regulatory Submissions, Approvals and Registrations|
|429||Chapter 6: Post-Market Phase|
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