• RF Quarterly

    Overcoming obstacles for SaMD development

    This article provides an overview of the quality system requirements concerning software as a medical device (SaMD), with an emphasis on learnings and considerations for implementing an agile or hybrid-based development process. The authors further expand upon topics unique to SaMD development, specifically the importance of dataset integrity during development, considerations for proactive postmarket surveillance and the interplay between cybersecurity and risk management...