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This book is a practical guide to meeting IEC 62304 software
development requirements within the context of an ISO 13485 quality
management system (QMS). It proves it can be done with a minimum
amount of friction, overlap, and back-and-forth between development
stages. It essentially shows you how you should shape your medical
software development processes to fit in with the QMS processes in
the smartest and leanest way possible. By following the advice in
this book, you can reuse processes from your QMS, ensure your
product realization processes meet the requirements for medical
software development, and marry all the requirements together using
tried and tested solutions into one efficient system. The expertise
of the authors here goes beyond just the experiences of one
real-world project as they tap into over 30 years of experience and
countless software and software assessment projects to distill
their advice. The book takes a hands-on approach by first teaching
you the top 25 lessons to know before starting to develop a process
for medical software development -- It then walks you through the
expectations placed on the key aspects of such a process by the key
standards. The book progresses from an overview of both standards
and the general requirements involved to a detailed discussion of
the expected stages from software development and maintenance to
risk management, configuration management, and problem resolution.
The book provides insightful advice on how the requirements of the
IEC 62304 software development lifecycle can be married with ISO
13485 QMS, how the development of the technical file should be
organized, and how to address conformity assessment, the daily
after approval, and the recent trends that will affect the industry
in the coming years. The book is modeled after the IEC 62304
standard and adopts its clause structure in the numbering of
sections for easy reference. The book does not attempt to replicate
either standard. For the ISO 13485 standard, it recites the
necessary requirements succinctly. For IEC 62304, the discussion is
in-depth and also addresses the impact of ISO 13485 on the
requirements discussed. In this way, the book drills into both
standards to expose the core of each requirement and shape these
into a practical, cohesive workflow for developing, maintaining,
and improving a Lean software development pipeline.
This book is a practical guide to meeting IEC 62304 software
development requirements within the context of an ISO 13485 quality
management system (QMS). It proves it can be done with a minimum
amount of friction, overlap, and back-and-forth between development
stages. It essentially shows you how you should shape your medical
software development processes to fit in with the QMS processes in
the smartest and leanest way possible. By following the advice in
this book, you can reuse processes from your QMS, ensure your
product realization processes meet the requirements for medical
software development, and marry all the requirements together using
tried and tested solutions into one efficient system. The expertise
of the authors here goes beyond just the experiences of one
real-world project as they tap into over 30 years of experience and
countless software and software assessment projects to distill
their advice. The book takes a hands-on approach by first teaching
you the top 25 lessons to know before starting to develop a process
for medical software development -- It then walks you through the
expectations placed on the key aspects of such a process by the key
standards. The book progresses from an overview of both standards
and the general requirements involved to a detailed discussion of
the expected stages from software development and maintenance to
risk management, configuration management, and problem resolution.
The book provides insightful advice on how the requirements of the
IEC 62304 software development lifecycle can be married with ISO
13485 QMS, how the development of the technical file should be
organized, and how to address conformity assessment, the daily
after approval, and the recent trends that will affect the industry
in the coming years. The book is modeled after the IEC 62304
standard and adopts its clause structure in the numbering of
sections for easy reference. The book does not attempt to replicate
either standard. For the ISO 13485 standard, it recites the
necessary requirements succinctly. For IEC 62304, the discussion is
in-depth and also addresses the impact of ISO 13485 on the
requirements discussed. In this way, the book drills into both
standards to expose the core of each requirement and shape these
into a practical, cohesive workflow for developing, maintaining,
and improving a Lean software development pipeline.
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