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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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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 Renée Matthews HTML 4 Software development Jaap Noordmans, BSc HTML 28 Overcoming obstacles for SaMD development Tahir Rizvi, MEng; Savannah Hari, BSc; and Chris Gilbert, BSc HTML 38 Clinical evaluation of software Zuzanna Kwade, MSc, PhD HTML 50 Safety risk management of software Mikael Dahlke, MSc, and Robert Ginsberg, MSc HTML 71 Security risk management Ben Kokx HTML
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