Postmarket Requirements for Medical Devices: A Practical Guide
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Author Acknowledgments
RAPS and the lead editors, Anu Gaur and Karen Zhou, thank the following subject matter experts for
sharing their experience and knowledge and volunteering their time to contribute to this first edition of
Postmarket Requirements for Medical Devices: A Practical Guide.
Rajaram Balasubramanian,
RAC-US, RAC-EU, PMP
Director, Regulatory Affairs
and Quality Assurance,
TIMEA
Elekta Medical Systems India
Pvt Ltd
India
Chapters 9 and 10
Karen Fan, MSc, RAC, Peng,
PMP
EU MDR Consultant
Johnson &Johnson Surgical
Vision Inc.
Canada
Chapter 3
Anu Gaur, PhD, MBA,
MSRA, RAC-US,
RAC-Global
President
SYNERGY Global
Regulatory Affairs
Consultancy, Inc.
US
Lead Editor, Preface, and
Chapter 1
Michelle Jump, MSc, RAC
CEO
MedSec
US
Chapter 18
Barbara Leukers, Dipl.
Chem (FH), RAC
Consultant
Leukers-Consulting
Germany
Chapter 8
Shikha Malik, MPharm, MS,
RAC-Devices
Senior Regulatory Affairs
Specialist
Medtronic
US
Chapter 2
Cathy Matthews, MSc
Regulatory Affairs Specialist
Edwards Lifesciences Canada
Inc.
Canada
Chapter 4
Sharon Perez, PhD
Vice President, Global
Medical Safety
Novocure
US
Chapters 11 through 17
Sharad Mi Shukla, RAC-US,
RAC EU
Director Regulatory Affairs
MedTech
Johnson &Johnson
Singapore
Chapters 9 and 10
Julia Stindl, PhD
Head of Global Post-Market
Safety
Novocure
Germany
Chapters 11, 12, 13, 16, and 17
Ana Subramanian, MSc,
PhD, RAC
Canada
Chapters 6 and 8
Echo Yu, MSc, RAC-Global
QA/RA Director
Sinocare Meditech, Inc.
Canada
Chapter 7
Karen Zhou, JD, MS, RAC-
Devices, RAC-Global
Faculty, MS Regulatory
Affairs Program
Northeastern University
Canada
Lead Editor, Preface, and
Chapter 5