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Preface
In a super-connected world of digitalization, where people around the globe spend hours each day on
their laptops, tablets, and smartphones, the medical devices industry has caught up. Many products are
enhanced with software. Devices now widely connect to the global internet of things. But in recent
years, we have seen a splurge moving beyond the physical boundaries of capital equipment, electron-
ically driven wheelchairs, and connected home care. And just as we moved into the world of apps,
known as Software as Medical Device (SaMD), the next transformation is at our doorstep: that of
Artificial Intelligence (AI).
While all of this is not entirely new, it has dawned that regulatory science is falling behind. Some
guidance is available in various jurisdictions, but a complete overview of the regulatory landscape for
SaMD is missing. That gap is being filled with this first edition of the RAPS book “Software as a Med-
ical Device: Regulatory and Market Access Implications.” In it, leading experts in this rapidly developing
field will take the reader on a journey through the core essentials:
• SaMD basics, including for IVDs
• Software classification
• Safety and security risk management of software
• Clinical evaluation of software
• Software development, including the use of open-source and third-party software components
• Usability engineering
• Artificial intelligence
• Quality and reliability of health apps
• Market access and digital distribution models
• Software liability
• Global software regulation
The reader will note that quite a few regulatory requirements pose interpretation challenges when
applied to software. Traditional interpretations sometimes need to be somewhat modified in line with
the requirements’ goals and intentions to make them applicable to software and allow for a robust val-
idation of the available dataset. Regulators require a similar understanding as they are reflecting on the
technical documentation provided by the software developers for their regulatory submissions.
In a fully connected world, it is great to see that now medical devices and IVDs are catching up to
match what we have become accustomed to in our daily lives. And slowly, as the device world is getting
used to the SaMD, the regulatory hurdle will be dropping.
We enjoyed bringing the authors, their knowledge, and experience together. In a fast-evolving
regulatory landscape, this book might guide both the novice and the experienced regulatory expert into
the new parts of our Medtech world: SaMD and AI.
Lead Editors
Koen Cobbaert, MSc
Senior Manager Quality, Standards, and
Regulations
Philips
Gert Bos, MSc, PhD, FRAPS
CSO, Executive Director, and Partner
Qserve Group
Preface
In a super-connected world of digitalization, where people around the globe spend hours each day on
their laptops, tablets, and smartphones, the medical devices industry has caught up. Many products are
enhanced with software. Devices now widely connect to the global internet of things. But in recent
years, we have seen a splurge moving beyond the physical boundaries of capital equipment, electron-
ically driven wheelchairs, and connected home care. And just as we moved into the world of apps,
known as Software as Medical Device (SaMD), the next transformation is at our doorstep: that of
Artificial Intelligence (AI).
While all of this is not entirely new, it has dawned that regulatory science is falling behind. Some
guidance is available in various jurisdictions, but a complete overview of the regulatory landscape for
SaMD is missing. That gap is being filled with this first edition of the RAPS book “Software as a Med-
ical Device: Regulatory and Market Access Implications.” In it, leading experts in this rapidly developing
field will take the reader on a journey through the core essentials:
• SaMD basics, including for IVDs
• Software classification
• Safety and security risk management of software
• Clinical evaluation of software
• Software development, including the use of open-source and third-party software components
• Usability engineering
• Artificial intelligence
• Quality and reliability of health apps
• Market access and digital distribution models
• Software liability
• Global software regulation
The reader will note that quite a few regulatory requirements pose interpretation challenges when
applied to software. Traditional interpretations sometimes need to be somewhat modified in line with
the requirements’ goals and intentions to make them applicable to software and allow for a robust val-
idation of the available dataset. Regulators require a similar understanding as they are reflecting on the
technical documentation provided by the software developers for their regulatory submissions.
In a fully connected world, it is great to see that now medical devices and IVDs are catching up to
match what we have become accustomed to in our daily lives. And slowly, as the device world is getting
used to the SaMD, the regulatory hurdle will be dropping.
We enjoyed bringing the authors, their knowledge, and experience together. In a fast-evolving
regulatory landscape, this book might guide both the novice and the experienced regulatory expert into
the new parts of our Medtech world: SaMD and AI.
Lead Editors
Koen Cobbaert, MSc
Senior Manager Quality, Standards, and
Regulations
Philips
Gert Bos, MSc, PhD, FRAPS
CSO, Executive Director, and Partner
Qserve Group