Workplan and Achievements

You will find current research tasks and successes already achieved
by the KIMEDS project here.

The partners involved in the KIMEDS project aim to make medical technology software certification more transparent and efficient for all stakeholders, and with our interdisciplinary team, KIMEDS is sure we can achieve our goals. In the course of the project, a proof-of-concept-tool will be developed that utilizes an ontology developed within the KIMEDS consortium. This work will be the basis for a new specification, which could be the basis for new international standards. With the help of appropriate AI supported software tools, complex specifications that are time consuming for humans to review can be checked for completeness and consistency, and their logical consequences can be verified. This should lead to a fundamental improvement in the safety, transparency and certification of medical devices.

The entire medical technology industry, which is already one of the most innovative industries in Germany, will benefit from the development of an AI-supported digital risk management tools.

Achievements and Outlook

KIMEDS has developed an ontology based upon ISO 14971 terminology and includes key aspects of Assurance Cases to ensure a common, and openly available, understanding of the structure of information. The KIMEDS ontology enables the analysis and reuse of domain knowledge and makes domain assumptions explicit. This builds the foundation necessary for AI-based analysis of digital risk management files that utilize the KIMEDS ontology.

Documentation about the KIMEDS developed “Riskman” ontology can be accessed here: https://w3id.org/riskman

Standardize a digital submission format

KIMEDS is working to standardize a digital submission format for risk management files in the VDE SPEC 90025-CRAFT MD. The specification is written in English, and will be free to access upon publication, ensuring it will reach a larger audience.

Proof-of-concept for digital risk management file data entry

KIMEDS has developed a proof-of-concept tool for digital risk management file data entry, display (both table and tree view), and submission (html) that fits the requirements established by the notified bodies and manufacturers, as described in the VDE SPEC 90025-CRAFT MD. A beta version of this tool will be available soon, so check back soon for updates.

Next steps

The next steps include getting feedback on the proof-of-concept tool to improve the user experience. KIMEDS is currently looking for innovative teams who are willing to digitally submit a RMF (risk management file) as part of their conformity assessment.

A core component of the KIMEDS vision is open source submission of portions of the RMF. Placing portions of the RMF in the public domain will increase transparency- and safety- of medical devices. Additionally, the data gathered in an open source repository can be used to help train the AI model, which will lead to new functionalities in our AI enabled RMF tool that can suggest potential risks or SDAs for classes of medical devices.