Access to Infrastructure & R&D Support service
Medical device cybersecurity services
Provided by Innokas Medical Oy · Finland
Service description
Innokas cybersecurity services cover everything needed to get the solution to the market: technical testing, evaluations and documentation and processes. Innokas offers specific service packages fixed/hour pricing based on the system scope. All the packages are part of the medical or healthcare product development. They fulfil some of the required R&D actions to improve cybersecurity of the product. These packages are targeted to R&D organisation working on regulated medical products software or hardware. Completing a package guarantees the cybersecurity is implemented with good workmanship and there is documentation as deliverable which can be shown to auditors when needed.
Packages are provided as a small scale projects and options: i) Cybersecurity plans, ii) Threat modelling, iii) Architecture security reviews, iv) Penetration testing (SW, HW, interfaces ), v) Source code (SAST) vulnerability scanning, and vi) SBOM auto-generation and CVE scanning solutions. The services may also include Consulting & Documentation in security compliance with MDR – MDCG 2019-16, FDA “cyberdevice” and IEC 81001-5 Health software and health IT systems safety, effectiveness and security requirements.