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The application of risk management principles for DHTs is not clearly defined and depends on whether the technology is classified as a medical product based on its intended use. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management.
The application of risk management principles for DHTs is not clearly defined and depends on whether the technology is classified as a medical product based on its intended use. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management.
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