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This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants. SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]
In this webinar recap, we discuss the general medical device safety and performance principles of Software as a Medical Device (SaMD) development.
Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks […]