Oxlantic - Cybersecurity
Reference number | |
Coordinator | Oxlantic Medical AB |
Funding from Vinnova | SEK 199 390 |
Project duration | June 2025 - December 2025 |
Status | Ongoing |
Venture | Medtech4Health: Competence Enhancement in SME |
Call | Medtech4Health: Competence Enhancement in Small Businesses 2025 |
Purpose and goal
Oxlantic aims to enhance MARIE´s cybersecurity for future Bluetooth-connected versions, meeting strict MDR/FDA requirements. The goal is to ensure robust data protection, security updates, and risk management, becoming a leader in portable, connected capnography and improving patient safety globally.
Expected effects and result
A complete cybersecurity strategy and documented processes for data protection, updates, and risk management will be in place. Oxlantic will gain internal expertise, enabling continued cybersecurity work independently. This ensures market access, reduced rework, and long-term compliance, reinforcing MARIE´s unique market position.
Planned approach and implementation
The project includes practical workshops, mentorship from experts in the field, and structured documentation. Activities cover training in cybersecurity standards (IEC 81001-5-1, ISO 27001, IEC 62304, ISO 14971, FDA guidances), risk analysis, threat modeling for Bluetooth/cloud communication, and integration into the Quality Management System (QMS). This approach builds competence through hands-on work with MARIE´s development.