2023年9月26日,FDA发布了关于医疗器械注册的网络安全最终版指南:Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions 官方链接如下: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDAwww.fda.gov/...
Cybersecurity Risks and Requirements for Medical Devices Regulatory requirements: Medical devices are subject to stringent regulations by bodies such as the FDA in the United States, the EMA in Europe, NMPA in China, and other regional regulatory agencies. These regulations require adherence to specifi...
现在,网络安全风险也需要管理。但是,14971程序并没有直接转化到这个领域,FDA的上市前网络安全指南草案建议制造商创建一个威胁模型 (Section V.A.1. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, 2022)。虽然威胁模型在IT领域比较常见,但对医疗器械制造商来说...
On September 27, 2023, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." As more medical devices are becoming interconnected, cybersecurity threats have ...
The FDA’s most recent guidance document, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” builds upon former ones and offers suggestions on how to improve medical device cybersecurity. This isn’t a medical device industry trend that’s ...
(FDA) has released guidance in the past about security in medical devices, the pace of technology warrants more frequent guidance documents. The latestFDA cybersecurity guidanceto be released is still in the draft stage, “Cybersecurity in Medical Devices: Quality System Considerations and Content ...
FDA issues final guidance document on postmarket cybersecurity for medical devices The US Food and Drug Administration (FDA) is encouraging medical device manufacturers to be more vigilant and build in safeguards throughout the product lifecycle to reduce health and safety risks. ...
1, 2023. The FDA provides recommendations for managing cybersecurity in the 2014 guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” and the 2016 guidance, “Postmarket Management of Cybersecurity in Medical Devices.” The FDA also recognizes ANSI/UL 2900...
FDA Looking at Gaps in the Cybersecurity of Medical DevicesAbraham Gitterman
Medical Device Cybersecurity Postmarket Management Services We specialize in delivering comprehensive postmarket cybersecurity support for medical device manufacturers, ensuring ongoing compliance with FDA and EU MDR requirements while maintaining device security and effectiveness throughout its lifecycle. Learn...