AI Assisted Certification of Medical Software
- August 1, 2022 – July 31, 2025
- funded by Federal Ministry of Education and Research (BMBF)
Safety certificates for medical software are so far unstructured and often spread over several documents. This hinders the efficient processing of these documents in the formal certification of medical products relying on software. An automation of the creation and the approval of safety certificates may lead to a significant speed-up in certification of medical products.
The goal of KIMEDS is the establishment of the method of the Assurance Case as an ontology-based safety documentation for automated verification and validation of risk-free medical software components. An assisting and explainable system is based on the regulatory foundations and enacts as a validating instance of the Assurance Case over the lifecycle of medical software. The creation of the safety documentation begins in the early stages of software development, which is then guided by a continuous check of validity through the system we develop. This system also supports the certification of Assurance Cases, leading to a significant increase in efficiency of the overall certification process.