Software maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic.
DetailsMedical device manufacturers are obliged to both describe the development process and create a development plan. Because both documents specify how medical devices will be developed, there is uncertainty as to which information belongs in which document. This article resolves this and also examines the software. It looks at the software development plan and the…
DetailsSince 2020, the German legislature has allowed the reimbursement of digital health applications (DiGA). DiGA manufacturers must fulfill several requirements for this. This article describes the steps required to do so.
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