
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.
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