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Search results for: Software as a Medical Device (SaMD)

MDR Rule 11: Classification Rules for SaMD with their benefits and challenges

Software development for medical devices has become significant with technology growth in recent years. However, improving patient care, diagnosis, and treatment through software as a Medical Device (SaMD) brings challenges, such as requiring specific regulations to ensure patient safety. Here enters MDR Rule 11, a crucial framework establishing Classification Rules for medical software. In this article, you will learn about the benefits and challenges associated with Rule 11, the criteria of MDR classification and the steps of deployment and regulation of SaMD applications.

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