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News: Device manufacturers can now address risk management with ISO standards

The International Organization for Standardization (ISO) announced its revised standard to address the application of risk management to medical devices. The standard highlights the detailed benefit that one can expect from devices, along with other additions and clarifications from previous versions.

The 36-paged guidance further notes more changes, which also includes “The requirements to disclose residual risks have been moved and merged into one requirement after the overall residual risk has been evaluated and judged acceptable."