Software as a Medical Device
Second Edition
v Regulatory Affairs Professionals Society
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.
EDITORS
Gert Bos, PhD, MSc, FRAPS
CSO
Qserve Group
Koen Cobbaert, MSc
Regulatory Science &Policy Expert
Philips
AUTHORS
Pat Baird, MSc, MBA
Senior Regulatory Specialist
Philips
Catarina Carrão, FAHA
Regulatory Clinical Development,
Evaluation and Assessment
BioSciPons
Koen Cobbaert, MS
Regulatory Science &Policy Expert
Philips
Mikael Dahlke. MSc
Retired
Coenraad Davidsdochter, MSc
Team Manager Regulatory Medical
Devices &Senior Consultant
Qserve Consultancy B.V.
Leon J. Doorn, MSc
Co-Founder &CEO
MedQAIR Services B.V.
Robert Ginsberg, MSc
Independent Consultant
Petra Hoogendoorn, MSc
Lead expert, CEN-ISO/TS 82304-2
Christie Hughes, MPH,
MLS(ASCP), RCC-IVDR
Director of Regulatory and
Compliance
Goldbug Strategies
Ben Kokx
Director Standardization Product
Security
Philips
Zuzanna Kwade, PhD, MS
Clinical Evaluation Manager
Dedalus
Zhuo Li, MSc
Regulatory Affair Manager
Philips
Charles McCay
Information Standards Architect
Ramsey Systems Ltd
Henk-Willem A. Mutsaers, MSc
Lead Auditor
Kiwa
Uta O. Rawson, JD
Senior Regulatory Legal Counsel
Philips
Siegfried Schmitt, PhD
Vice President Technical
Parexel
Agnes Szoboszlai, LLM
Regulatory Legal Counsel
Philips
Jouke Waleson
Founder
Comper B.V.