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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.
1 Introduction: Software as a medical device
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
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