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Navigating Cybersecurity Compliance: The Cyber Compass for Medical Device Manufacturers

Abstract

Connected Medical Devices (CMDs) show great potential for improving patients' quality of life, and manufacturers work tenaciously to get such products to the market as quickly as possible. However, to protect the patients, the CMDs need to be developed in accordance with applicable regulations. Therefore, manufacturers must not only identify and implement relevant requirements for their CMDs, but also document their product lifecycle management, their approach to risk management and cybersecurity approach. Inspired by curated lists for cybersecurity management in other domains ("Awesome Lists"), the Cyber Compass tool has been developed to provide a similar overview of relevant cybersecurity resources for the healthcare domain. With its user-friendly interface and crowd-sourced nature, the tool helps manufacturers navigate and filter regulatory resources, alleviating the compliance burden. In addition to identifying the relevant documents and requirements, the tool also addresses the bigger challenge of fully understanding the regulatory requirements and implementing the necessary measures relevant for all stakeholders involved in the lifetime of the CMD. The results from the evaluation of the Cyber Compass tool indicate that stakeholders of CMDs can successfully use the tool for this purpose.

Category

Academic chapter

Language

English

Affiliation

  • SINTEF Digital / Software Engineering, Safety and Security

Date

01.05.2026

Year

2026

Publisher

Springer

Book

Secure and Resilient Digital Transformation of Healthcare : Third International Workshop, SUNRISE 2025, Halden, Norway, November 24-26, 2025, Proceedings

ISBN

9783032222411

Page(s)

130 - 130

View this publication at Norwegian Research Information Repository