Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications
£50.00
Strengthen cybersecurity compliance and apply the NIST SSDF framework to build secure, risk-appropriate development processes for medical device software
English
This article by Gerald Rigdon, Trevor Greene, Jonathan Kelly, and Michael Seeberger develops a medical device manufacturer Profile based on the National Institute of Standards and Technology (NIST) Secure Software Development Framework (SSDF). The intended use of this Profile is the development of secure low to moderate risk medical device applications. It further serves as a guide that maps NIST SSDF practices to the Secure Product Development Framework (SPDF), as presented by the US Food and Drug Administration in its pre-market cybersecurity guidance. Finally, the article demonstrates a practical, risk-based approach for choosing a cybersecurity framework that is more appropriately scaled for lower risk medical device applications.
Specification: 12 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2025 issue of the Journal of Medical Device Regulation.
