Important results from the project
The goals have been met. A defined framework for cybersecurity is developed and ready to be integrated into our QMS to meet MDR/FDA. This ensures risk management for MARIEs Bluetooth-version.
The knowledge transfer has been carried out completely according to plan. Through workshops, expertise has been transferred to the team for independent work. An important results is that we now have a methodology where cybersecurity is an integrated part of the development.
Expected long term effects
The project secures market access in the EU and the US by enabling us to meet the MDR/FDA-eligibility requirements for cybersecurity. The internal expertise we have built up means we can continue to operate our security work independently going forward.
This enables, among other things, remote monitoring with MARIE, which strengthens patient safety. The solution also contributes to sustainability by reducing plastic waste through fewer disposable items.
Approach and implementation
The project was implemented via expert-led workshops and mentoring as planned. The focus was on practical threat modeling of Bluetooth and cloud communication as well as risk analyses. In parallel, governing documents were developed to integrate security processes into our QMS according to IEC 81001-5-1. The work was concluded with vulnerability analyses and a review of the SBOM, which ensured knowledge transfer to the team.
The project description has been provided by the project members themselves and the text has not been looked at by our editors.
