BAYOOSOFT Themis, formerly Risk Manager, is browser-based multi-user software for process-guided documentation. It consolidates information into a single source of truth and supports technical documentation for medical devices and in vitro diagnostics under MDR and IVDR, risk management, and the setup of quality and information security management systems (QMS and ISMS). Teams collaborate with comments and chat, and an audit trail supports traceability. Its predecessor dates back to 1998 and has been developed continuously since.
Themis comes from BAYOOSOFT GmbH in Darmstadt, Germany, part of the BAYOONET Group; no foreign parent company was found. The sources do not say whether the software runs at the customer or is hosted by the vendor, and no data-centre location for customer data was found, so the EU is only an assumption based on the headquarters. No open-source code is mentioned. Ask the vendor how the solution is delivered before entrusting sensitive documentation to it.