Building Cloud-Connected Software as a Medical Device: Key Architecture and Compliance Needs

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Cloud-connected Software as a Medical Device (SaMD) is transforming clinical application development by enabling real-time data sync, AI-driven decision support, and remote patient monitoring. Unlike standalone medical software, these systems integrate secure cloud infrastructure to support continuous device communication, over-the-air updates, and centralized analytics. A modern SaMD architecture spans multiple layers, including device endpoints, edge processing, secure API gateways, cloud backends, and specialized data storage. Building such systems demands expertise in security protocols like OAuth 2.0 and OpenID Connect, as well as cloud-native practices such as containerization, CI/CD pipelines, and infrastructure as code. Healthcare technology teams must also address strict regulatory compliance and interoperability requirements throughout the development and deployment process.

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