Best practices for medical device cybersecurity planning from a US perspective
£35.00
Ensure robust cybersecurity measures for your devices by following proven best practices from a US perspective, safeguarding both data and patient safety
English
The medical device cybersecurity landscape continues to evolve rapidly with increasing medical device connectivity and an increased frequency and severity of cybersecurity threats to the healthcare sector. Cybersecurity threats that target medical devices can render medical devices and hospital networks inoperable, shut down healthcare operations, delay critical patient care, reveal sensitive patient data, and necessitate costly recovery efforts. Given this, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become increasingly important for the entire medical device community and all stakeholders. In this article, Shilpa Rapaka looks at what the new Food and Drug Administration (FDA) pre-market cybersecurity guidance means for device manufacturers, and offers some best practice solutions for manufacturers to consider in their cybersecurity plans. The article also clarifies how a company should plan for cybersecurity documentation in an FDA submission, and details the required cybersecurity documents. It also discusses how device manufacturers should prepare for the path forward.
Specification: 7 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2024 issue of the Journal of Medical Device Regulation.
