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From Simulation to Clinical Trials: Building a Risk-Reduced V&V Workflow

What ISO 80601-2-61:2017 defines and how to get prepared for it

The ISO 80601-2-61:2017 standard defines clinical evaluation methods for pulse oximeter devices. Clinical trials are costly, time-intensive, and operationally complex. Because failures at this stage can lead to schedule delays, redesign, or changes to performance claims, it is important to verify device performance before entering clinical evaluation.

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