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T4M: CodeMeter brings real traceability to medical device software

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Wibu-Systems answers the critical needs of medical technology enterprises

CodeMeter records when software and medical devices are accessed for the reliable tracing of what was changed, when, and by whom.

Wibu-Systems, the leading provider of software protection, licensing, and security solutions, is joining the VDMA exhibit (hall 10, booth 124a) at the medical technology fair MedTecLIVE with T4M from 3 to 5 May. The company’s expo team will be on site to introduce the CodeMeter technology and show visitors how CodeMeter tools can guarantee traceability with cryptographically protected information.

Traceability matters. For medical technology businesses, this is true in more than one way: Medical devices in the field must only run the software that was certified for them, and uncertified software should not be allowed to run on these machines. Added to that, the makers of medical devices need to have a record of when their software and hardware was accessed and by whom. This is essential for tracing back any changes, as tampering with the software or its intricate configurations can have undesirable, often critical repercussions on many levels, from accurate usage monitoring and billing to reliable diagnostics performance. If the worst came to the worst, this could have serious real-life consequences for medical treatments and patients’ health outcomes.

The makers of medical devices can use Wibu-Systems’ CodeMeter technology to encrypt and sign their applications and data. On top of software protection and safeguards against reverse engineering or smart licensing of individual features for authentication and monetization, CodeMeter provides the level of traceability that the German Act on Medical Devices demands. The cryptographic keys that make all of this possible are managed, securely and automatically, by CodeMeter, and the entire solution is designed to integrate smoothly with existing processes on all common technology platforms.

Stefan Bamberg, Senior Key Account & Partner Manager at Wibu-Systems, emphasizes: “For medical devices in particular, our CodeMeter technology is a perfect fit. It fulfils many of the needs of medical device makers with a single solution: Authentication, know-how protection, monetization, and traceability. And for the latter, that means traceability on both levels, for the certified software itself and for tracking any changes to it. I am looking forward to meeting my colleagues from the medical technology business and exploring these issues in more detail with them at T4M.”