By MSc Koen Cobbaert, FRAPS Gert Bos, MSc, PhD, Gloria Hall
Finding your way through the regulations, state-of-the-art standards, and interpretations applicable to health software, and in particular, software as a medical device (SaMD), can be challenging. Software as a Medical Device, Regulatory and Market Access Implications offers a guide through this complex landscape and provides the expertise of leading software experts. RAPS new topical book will support readers as they determine whether their software is subject to medical device regulations across the world, how to classify their software, understand the regulatory implications, and develop and optimize their strategy for regulatory submissions and market access. This book will help companies understand their legal obligations and liabilities, providing readers with the necessary tools to plan for the safety, security, usability, and clinical evaluation of their software. It also will help readers identify possible roadblocks and pitfalls to avoid. Readers will be able to instantly apply the methodology in the book to assess business and product plans, identify possible roadblocks and pitfalls, avoid surprises during software development, regulatory submissions, and software distribution, and convince decision makers to grant your software a place into the care pathways.

Product Details

• Publisher ‏ : ‎ Regulatory Affairs Professionals Society (RAPS) (January 1, 2021)
• Language ‏ : ‎ English
• ISBN-10 ‏ : ‎ 1947493612
• ISBN-13 ‏ : ‎ 978-1947493612
• ISBN-13 ‏ : ‎ 9781947493612