iii
Foreword
The foreword to the first edition of this book started out by noting the increasingly broad scope of
products being designated as medical devices. As technologies advance, this continues to remain true
and expands further to provide new diagnosis or treatment modalities toward the needs of patients.
With this advancement, one must anticipate corresponding concomitant changes to the regulations
and requirements governing these products. The technological evolution requires new regulatory
approaches to ensure continued confidence in the safety and efficacy of medical devices. Regulations
are not static, they evolve constantly, regardless of which country serves as the source of the products.
Over the period since the last edition, major regulatory changes pertaining to medical devices have
been witnessed in places like the European Union and the US, among others.
As the author described in Chapter 1, healthcare is undergoing a radical transformation driven
by uncontrollable cost increases, higher healthcare needs and increased regulatory scrutiny, as well as
a shift in payment systems and new payment models. To survive under this environment, healthcare
providers are focusing more than ever on controlling the cost of care, being more efficient and deliv-
ering improved patient care. As this shift expands, a stakeholder’s willingness to pay for a medical
device will be tied to its impact on patient outcomes and performance metrics, and medical device
manufacturers need to implement a collaborative and comprehensive approach in their product devel-
opment process (PDP) with customer adoption as the goal involvement by regulatory professionals
early in the process is critical.
While the core educational curriculum for regulatory professionals remains generally the same,
this edition captures the aforementioned evolutions and provides a resource of uniform value to both
the experienced regulatory professional and those entering the profession and designing their own
pathway to success in this vastly enriching field. It can be used as a contemporary and integral book-
shelf reference in regulatory affairs departments of all sizes, as well as a routine textbook in expanding
academic curricula in regulatory affairs and quality systems.
Our thanks to the many authors who volunteered their time and knowledge in contributing to
this book, and especially to the late Pamela Jones, RAPS senior editor, a dear friend who guided the
inception of both editions, and whose editorial vision and dedication was inspiring to us all.
Editors-in-Chief
Peter A. Takes, PhD, RAC, FRAPS Susumu Nozawa, RAC, FRAPS
Principal Head of Regulatory Policy – North America
Regulatory Intelligence Associates, LLC Siemens Healthineers
Foreword
The foreword to the first edition of this book started out by noting the increasingly broad scope of
products being designated as medical devices. As technologies advance, this continues to remain true
and expands further to provide new diagnosis or treatment modalities toward the needs of patients.
With this advancement, one must anticipate corresponding concomitant changes to the regulations
and requirements governing these products. The technological evolution requires new regulatory
approaches to ensure continued confidence in the safety and efficacy of medical devices. Regulations
are not static, they evolve constantly, regardless of which country serves as the source of the products.
Over the period since the last edition, major regulatory changes pertaining to medical devices have
been witnessed in places like the European Union and the US, among others.
As the author described in Chapter 1, healthcare is undergoing a radical transformation driven
by uncontrollable cost increases, higher healthcare needs and increased regulatory scrutiny, as well as
a shift in payment systems and new payment models. To survive under this environment, healthcare
providers are focusing more than ever on controlling the cost of care, being more efficient and deliv-
ering improved patient care. As this shift expands, a stakeholder’s willingness to pay for a medical
device will be tied to its impact on patient outcomes and performance metrics, and medical device
manufacturers need to implement a collaborative and comprehensive approach in their product devel-
opment process (PDP) with customer adoption as the goal involvement by regulatory professionals
early in the process is critical.
While the core educational curriculum for regulatory professionals remains generally the same,
this edition captures the aforementioned evolutions and provides a resource of uniform value to both
the experienced regulatory professional and those entering the profession and designing their own
pathway to success in this vastly enriching field. It can be used as a contemporary and integral book-
shelf reference in regulatory affairs departments of all sizes, as well as a routine textbook in expanding
academic curricula in regulatory affairs and quality systems.
Our thanks to the many authors who volunteered their time and knowledge in contributing to
this book, and especially to the late Pamela Jones, RAPS senior editor, a dear friend who guided the
inception of both editions, and whose editorial vision and dedication was inspiring to us all.
Editors-in-Chief
Peter A. Takes, PhD, RAC, FRAPS Susumu Nozawa, RAC, FRAPS
Principal Head of Regulatory Policy – North America
Regulatory Intelligence Associates, LLC Siemens Healthineers