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Author: Ashish Salunkhe | October 18, 2023
In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...
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Author: Ashish Salunkhe | October 17, 2023
In September 2023, the FDA finalized its medical device cybersecurity guidance for premarket submissions. The updated document, “Cybersecurity in Medical Devices: Quality System Considerations...
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