vii
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the
following subject matter experts who shared their experience and knowledge and volunteered their time
by contributing to this book.
Ben Kokx
Director Product Security
Philips
Netherlands
Zuzanna Kwade, MSc, PhD
Clinical Evaluation Lead
Dedalus HealthCare GmbH
Belgium
Charles McCay
Health Information Standards Architect
Ramsey Systems Ltd
UK
Henk-Willem Mutsaers, MSc
Senior Consultant
Qserve Group
Netherlands
Jaap Noordmans, BSc
Qserve Group
Senior Consultant
Netherlands
Siegfried Schmitt, PhD
Vice President Technical
Parexel
UK
Tobias Schreiegg
Director Regulatory Affairs
Siemens Healthineers
Germany
Pat Baird, MSc, MBA
Senior Regulatory Specialist
Philips
US
Marc Coomans, MSc
User Experience Designer
Belgium
Mikael Dahlke, MSc
Principal Quality and Regulatory Consultant
QAdvis AB
Sweden
Robert Ginsberg, MSc
Principal Quality and Regulatory Consultant
QAdvis AB
Sweden
Julie Hantson
Lawyer
Hantson Advocatenkantoor (HA Law)
Belgium
Petra Hoogendoorn
Researcher
National eHealth Living Lab (Leiden University
Medical Center)
Netherlands
Christie Hughes, MPH, MT (ASCP)
Senior Consultant
Qserve Group
US
Tifanny Istamto, MBA, MSc
Strategic Account Manager Public
Alcon
Netherlands