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Medical device
Sumatha Kondabolu

Software Validation for Software as a Medical Device (SaMD): Ensuring Safety and Efficacy

Software Validation for Software as a Medical Device (SaMD) is a critical process that ensures the safety, efficacy, and regulatory compliance of software intended for medical purposes. Unlike traditional medical devices, SaMD operates independently of physical hardware, making its validation process unique and complex. This article delves into the key steps, regulatory requirements, and best practices involved in validating SaMD, providing valuable insights for developers, manufacturers, and regulatory bodies.

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