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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Chapter 1: Introduction
Chapter 2: Software as a Medical Device
Chapter 3: Software as an IVD Medical Device
Chapter 4: Classification of Medical Device Software
Chapter 5: Clinical Evaluation of Software
Chapter 6: Safety Risk Management of Software
Chapter 7: Security Risk Management
Chapter 8: Software Development
Chapter 9: Open Source and Third-Party Software Components
Chapter 10: Software Usability Engineering
Chapter 11: Artificial Intelligence
Chapter 12: Quality and Reliability of Health Apps
Chapter 13: Regulatory Implications of Digital Distribution Models for Medical Device Software
Chapter 14: Market Access and Reimbursement for Digital Health Technologies
Chapter 15: Software Liability
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 SaMD, 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 SaMD. 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 SaMD a place into the care pathways.