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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
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4   Software development
         Jaap Noordmans, BSc
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28  Overcoming obstacles for SaMD development
           Tahir Rizvi, MEng; Savannah Hari, BSc; and Chris Gilbert, BSc
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38  Clinical evaluation of software
           Zuzanna Kwade, MSc, PhD
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50  Safety risk management of software
           Mikael Dahlke, MSc, and Robert Ginsberg, MSc
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71  Security risk management
           Ben Kokx
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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
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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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Previous issues

• Global clinical trials
• Artificial intelligence in regulatory affairs
• Quality and compliance
• RAPS Convergence 2021

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