🚀 2024.1
Release Notes
✨ Features
F2401_01: Guidance for risk classification according to MDR 2017/745
BAYOOSOFT Themis now offers you a structured guide to determine the risk class according to MDR 2017/745. This risk classification guide is an extension of the technical documentation guide and provides you with a clear and efficient method to determine the risk class of your medical devices in compliance with the regulations.
Once all the required questions from the questionnaire have been answered, the risk class determined is displayed as follows:
F2401_02: Guidance for risk classification according to IVDR 2017/746
With this new release 2024.1 you can get access to the guidance according to IVDR 2017/746 in order to determine the risk class of your product according to in-vitro diagnostics. After answering all the required questions, the determined risk class will be displayed in the "Risk class" tab of the same name.
This structured risk classification guide is an extension of our Technical Documentation Guide and provides you with a clear and efficient method to determine the risk class of your in vitro diagnostics according to the regulations.
F2401_03: Efficient requirements management in accordance with IEC 62304
Requirements analysis is an indispensable part of the efficient and error-free development of complex medical device systems. It is particularly important for integrated product- and system concepts as well as development based on division of labor. By precisely recording, specifying and validating requirements, potential sources of error can be identified at an early stage and proactively addressed. The results are improved product quality, shorter development times and ultimately cost savings.
With the new "Requirements Engineering" module, BAYOOSOFT Themis now offers you the option of recording all your requirements, associated test cases and -protocols in a structured manner. The requirements to be defined can be grouped into documents (e.g. user requirements, design specifications, etc.). The requirements can be linked across the defined documents and also to the associated test cases in order to ensure traceability.
F2401_04: Updating the task status in a new version
If you create a new version of your product during the product lifecycle phase, all tasks in this new version are automatically set to "New" status.
This means that the people working on the tasks in the newer version are automatically reminded of the new evaluation in Themis. This ensures that no tasks are overlooked or forgotten, which increases your productivity and improves timeline compliance.
📐 Enhancements
E2401_01: New table of contents for the complete report
In order to provide you and your notified body with a quick overview of the documents included in the overall report, the table of contents is now available at the top level of the folder structure. This lists all the files in the folder and their full document titles, structured according to the various chapters. This offers you and your notified body a first point of contact for quick access to your technical documentation.
E2401_02: Updating Themis reports
BAYOOSOFT Themis introduces the revised report generation to further facilitate your experience with our services. For this purpose, the path of the attachment is clearly displayed in the report as follows:
Various optimizations have been made to the generated technical documentation so that you can concentrate on the essentials:
- The files in the folder structure are now named according to the document headings
- An overview can be found in the table of contents described in E2401_01
- The contents of the respective documents have been restructured so that the key data of the project and the task ID from BAYOOSOFT Themis are moved to the background and the heading and the actual contents to the front.
E2401_03: Mobile View
In this release, the user interface has been optimized for use on mobile devices, especially in tablet format. For example, you can now easily and simply release individual tasks while you are on the move.
E2401_04: Cross-module linking of tasks in one version
Linking tasks across modules is an effective way of establishing connections between different parts of your project and ensuring the coordination of workflows. This allows you to ensure that all relevant tasks and work steps are linked together, regardless of which area of your technical documentation you are in. For example, you can link the MDR task "Single Registration Number (SRN)" with the GSPR task "Transportation and Storage".
E2401_05: Improved MDR and IVDR Guidance
For many tasks of the Documentation Guides for MDR 2017/745 and IVDR 2017/746, the regulations provide comprehensive information that you must take into account when creating your technical documentation. So that you do not have to open the respective regulation in parallel and view the relevant passages, we have integrated them into the tasks at the relevant points as supplementary information including a precise reference.
🐞 Bugfixes
Minor Bugfixes
Product Release Approval
The features, enhancements and bug fixes listed above have been approved based on the following steps of the release process.
| # | Milestone | Responsibility | Date |
|---|---|---|---|
| 1 | Unit Tests: All unit tests were successfully executed after the implementation was completed. | Development Team | 16.02.2024 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 23.02.2024 |
| 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 | 18.03.2024 |
| 4 | Release Approval: Based on the verification results of previous steps, the features, enhancements and bug fixes were approved and released as a new version of the product. | Product Manager | 20.03.2024 |
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.