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...
In September 2023, the FDA finalized its medical device cybersecurity guidance for premarket submissions. The updated document, “Cybersecurity in Medical Devices: Quality System Considerations...
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...