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🚀 2025.3

Release Notes

✨ Features

F2503_01: FMEA Methodology (Failure Mode and Effects Analysis)

With this release, FMEA methodology has been integrated into BAYOOSOFT Themis. This enables the structured evaluation of potential failure modes using the Risk Priority Number (RPN), which is calculated based on Detection, Severity, and Occurrence. Users can define the evaluation components in the FMEA catalogue and set a numerical acceptance limit. Themis automatically calculates the RPN and indicates whether the limit has been exceeded. The three types of FMEA are supported: System FMEA (sFMEA), Design FMEA (dFMEA) and Process FMEA (pFMEA).

F2503_02: Extension of Risk Analysis to Process Variants

In addition to the existing risk analysis, a new variant is now available. This allows risk analyses to be performed for processes as well.

F2503_03: Compact Impact Analysis (Part 1)

When the status of a task is changed from ‘Approved’ to “New”, all linked tasks that depend on this task are automatically set to ‘In Review’. This ensures that dependent tasks are also reviewed if adjustments are necessary. The automatic status change only affects tasks that were previously in the ‘Approved’ status.

F2503_04: Avoid redundant tasks

Information that is used in multiple documents can now be linked and shared between documents. Redundant content is consolidated into shared tasks, so that information only needs to be maintained once. For existing projects, a migration path is available to transfer existing content into the new structure.

📐 Enhancements

Predefined links between tasks in ISO 9001, ISO 13485 and ISO 27001 documents are available. The assignments automatically show which requirements in the individual documents correspond in terms of content.

E2503_02: Delete projects

For better project management and greater clarity in project administration, projects can now be deleted.

Product Release Approval

The features and enhancements listed above have been approved based on the following steps of the release process.

# Meilenstein Verantwortlichkeit Datum
1 Unit Tests: All unit tests were successfully executed after the implementation was completed. Development Team 28.10.2025
2 Sprint Acceptance Tests: All listed user stories and bug fixes were implemented according to the functional specification. Service Team 10.12.2025
3 Performance Qualification: The system has been verified against the PQ tests to proof that it meets the requirements, technical specifications and assessment criteria of Software Validation acc. to ISO 13485. Validation Team 11.12.2025
4 Release Approval: Based on the verification results of previous steps, the features and enhancements were approved and released as a new version of the product. Product Manager 11.12.2025

This release process is documented to comply with the BAYOOSOFT quality management system.

Do you have any further questions?

Here you will find the contact details of our Service Team.