Digital risk file for medical devices

The presentation describes the task and initial results of the KIMedS research project, which has set itself the goal of introducing digital elements in the evaluation and control of medical device risks in practice and thus establishing knowledge databases.
In the first step, the task and solution of the VDE SPEC 90025 "Medical Devices - Risk Management: Framework of a Computerised Risk Analysis Format for Transmission and Submission (MDCRAFTS)" is presented:
Based on a concept modelling of the terms from ISO 14971, a data model is derived in this VDE SPEC, and an internal storage format and a storage and communication format are specified based on this.
In the KIMedS project, the digitalisation of the risk file is a first step towards the creation of knowledge databases, with which the creation and checking of risk files by rule-based systems is to be introduced and the operation of an eco-system for solution modules for safety measures in medical technology is to be made possible.

Please note: the presentation will be held in German. The presentation will be translated into English via voice-to-text so that you can follow the lecture live in written form via a monitor.

Supported by: ZVEI e.V.