Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485

This book provides a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). It offers advice on how to shape medical-software development processes to fit in with QMS processes efficiently,reuse processes from the QMS,and marry all requirements together using tried and tested solutions. The book takes a hands-on approach, teaching the top 25 lessons to know before starting development and walking through the expected stages from software development to risk management. It is modeled after the IEC 62304 standard and adopts its clause structure for easy reference.

Format: Unspecified
Length: 338 pages
Publication date: 13 November 2023
Publisher: Taylor & Francis Ltd

This comprehensive guide offers practical insights into meeting the IEC 62304 software-development requirements within the framework of an ISO 13485 quality management system (QMS). The book demonstrates that achieving this integration can be accomplished with minimal friction, overlap, and back-and-forth between development stages. It provides a roadmap for shaping medical-software development processes to seamlessly align with QMS processes, optimizing efficiency and effectiveness.

By leveraging the expertise of the authors, who draw from over 30 years of experience and numerous software and software-assessment projects, the book offers invaluable advice. It begins by imparting the top 25 lessons essential for understanding the complexities of medical-software development. It then guides readers through the expectations outlined by key standards, covering the entire development and maintenance lifecycle, including risk management, configuration management, and problem resolution.

The book goes beyond mere theoretical discussions, providing practical guidance on how to harmonize the requirements of IEC 62304 with an ISO 13485 QMS. It explores strategies for organizing the development of the technical file and addresses conformity assessment, daily after-approval processes, and emerging trends shaping the industry.

By following the principles outlined in this book, organizations can ensure the development of high-quality medical software that meets regulatory standards and enhances patient safety. It serves as a valuable resource for software developers, quality assurance professionals, and anyone involved in the medical software development lifecycle.

Weight: 700g
Dimension: 178 x 255 x 23 (mm)
ISBN-13: 9781032594729