RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide
Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global market.With a number of major regulatory changes affecting medical devices since the first edition was published four years ago, the new Device Strategy book has been completely revised and updated to cover the latest regulations along with timely information on such rapidly changing areas as cybersecurity, software as a medical device, and mobile medical applications.
As co-editors, Susumu Nozawa, RAC, FRAPS, and Peter A. Takes, PhD, RAC, FRAPS, write in the book’s Foreword, “The technological evolution requires new regulatory approaches to ensure continued confidence in the safety and efficacy of medical devices. Regulations are not static, they evolve constantly.”
The book walks readers through the fundamental elements of an effective regulatory strategy, the use of standards and regulatory resources for strategy development, and how to establish and work with the kind of cross-functional team necessary to create and implement a comprehensive strategy. Given the increasing importance of taking into account payment, product value and other patient- and customer-focused criteria, this edition also adds a new chapter on successful commercial product launches—what they look like and how to achieve them.
Medical Device Regulatory Strategy, Second Edition comprises the combined expertise of 29 experienced regulatory professionals, authoring 22 chapters, covering topics including risk evaluation and mitigation; clinical trials; advertising, promotion and labeling; combination products; in vitro diagnostic devices; and cell therapy products. Readers will come away with a better understanding of the key factors for successful commercialization and the important role regulatory professionals play.
Medical Device Regulatory Strategy, Second Edition is available in hardcover and e-book formats. View the table of contents and read a free chapter, Use of Standards in Medical Device Global Regulatory Strategy.