Cybersecurity is the practice of protecting computers and electronic communication
systems as well as the associated information. Protecting confidentiality, integrity, and availability are common security objectives for information systems. This forms the foundation for cybersecurity.
“Software as a Medical Device” (SaMD) is broadly defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Whether using a predictive (Waterfall; V- model) or adaptive methodology (Agile), it is imperative that the following processes and their corresponding outputs to be incorporated in the SaMD Development:
Manufacturers of SaMD must report any correction or removal of an SaMD if action was initiated to:
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