Medical Device Regulatory Practices ― An International Perspective

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.

Val Theisz is a regulatory professional with over 15 years’ experience in medical device regulations, of which she spent eight years in leadership roles in regulatory affairs, regulatory operations, and quality assurance. She holds a master’s degree in electrical engineering from the Polytechnic University of Timisoara, 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.

Working on both sides of the regulatory divide—as a reviewer and quality systems auditor with a major EU Notified Body (7 years) and in roles with responsibility for obtaining regulatory approvals and maintaining regulatory compliance (10 years)—enabled Val to gain an in-depth understanding of the typical challenges facing medical device companies, both small start-ups and large organizations. One of her achievements was obtaining the CE marking approval for a life-sustaining active implantable medical device within six months from the date of submission. During a five-year stint as regulatory operations manager responsible for regulatory systems and processes with one of the largest pharmaceutical companies, Val implemented electronic data management systems for a large product portfolio and learned about process improvement techniques.

Val’s passion for building and developing regulatory teams, for improving and streamlining business processes, and in general for doing the right thing motivated her to spend late nights and weekends writing this book.