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2022 RF Quarterly Q1

RF Quarterly,  April 2022:
Software as a Medical Device

Welcome to the April issue of RF Quarterly in which global experts on software as a medical device (SaMD) address topics such as software development and the associated challenges, clinical evaluation of SaMD, safety and security risk management, digital therapeutics, and more.

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Table of Contents

1    Introduction: Software as a medical device
          Renée Matthews
4   Software development
         Jaap Noordmans, BSc
28  Overcoming obstacles for SaMD development
           Tahir Rizvi, MEng; Savannah Hari, BSc; and Chris Gilbert, BSc
38  Clinical evaluation of software
           Zuzanna Kwade, MSc, PhD
50  Safety risk management of software
           Mikael Dahlke, MSc, and Robert Ginsberg, MSc
71  Security risk management
           Ben Kokx

83  Digital therapeutics: Leveraging the SaMD framework for regulatory success
           Jainam Shah, MS, MBA, PMP; Geena George, MS; George Cusatis MS, RAC;
           and Darin Oppenheimer DRSc, FRAPS, RAC, PMP



Upcoming in RF Quarterly  
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
  • RAPS 2021 Convergence (December 2022)
To contribute, email rmatthews@raps.org.
For more information, see Guidelines for Authors and the 2022 Editorial Calendar.
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  • Regulatory Intelligence
  • The Shifting Global Regulatory Landscape
  • Global Regulatory Strategies and Best Practices
  • The Strategic Role of the Regulatory Professional
  • Risk Management and Quality
  • Global Strategies for Drugs and Devices
  • Executive Leadership and Management
  • Global Regulatory Policy and Strategy

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