Fda Medical Device Classification


Medical Software Compliance & HIPAA’s Protection of Patient Data

Software as a Medical Device (SaMD) is defined by the FDA as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Within the medical device industry, SaMD and cybersecurity have been a topic of conversation as the FDA implements a regulatory […]

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FDA Medical Device Classification

FDA has a public obligation to regulate and control the distribution of medical devices for public safety. To do this, medical device manufacturers provide information and data about their product to the FDA to assess the product for safety and effectiveness. However, not all products require the same level of review by the FDA. A […]

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