🚀 2023.4
Release Notes
✨ Features
F2304_01: MDR 2017/745 - General Safety and Performance Requirements
BAYOOSOFT Themis now enables you to perform conformity assessment with the General Safety and Performance Requirements described in Annex I of the European Regulation 2017/745 on Medical Devices. In order to prove the conformity of your Medical Devices, you now have the option of recording the applicability of each requirement and the methods used to prove it. You can also record the standards and regulations you have applied and print everything together in one report.
F2304_02: IVDR 2017/746 - General Safety and Performance Requirements
BAYOOSOFT Themis now enables you to perform conformity assessment with the General Safety and Performance Requirements described in Annex I of the European Regulation 2017/746 on In Vitro Diagnostics. In order to prove the conformity of your In Vitro Diagnostic Medical Devices, you now have the option of recording the applicability of each requirement and the methods used to prove it. You can also record the standards and regulations you have applied and print everything together in one report.
F2304_03: Australian Therapeutic Goods (Medical Devices) Regulation 2002 - Essential Principles
BAYOOSOFT Themis now enables you to perform conformity assessment with the Essential Principles described in Schedule I of the Australian Therapeutic Goods (Medical Devices) Regulation of 2002. In order to prove the conformity of your Medical Devices, you now have the option of recording the applicability of each requirement and the methods used to prove it. You can also record the standards and regulations you have applied and print everything together in one report.
F2304_04: Canada SOR/98-282 - Safety and Effectiveness Requirements
BAYOOSOFT Themis now enables you to perform conformity assessment with the Safety and Effectiveness Requirements described in Clause 10-23 of the Canadian Medical Device Regulation SOR(98-282). In order to prove the conformity of your Medical Devices, you now have the option of recording the applicability of each requirement and the methods used to prove it. You can also record the standards and regulations you have applied and print everything together in one report.
F2304_05: Consolidated Conformity Assessment for the Essential Principles of various target markets
Many markets in which you want to place your Medical Device require a conformity assessment according to defined Essential Principles (see previous features). Often, similar requirements are stipulated on the Medical Device, which must therefore be answered several times. To keep the effort for you as low as possible, we have combined the requirements of the target markets into tasks in the GSPR module and provided them with a shared question catalogue. In this, you define your target markets and add various information about your Medical Device. The system then shows or hides the relevant requirements and automatically answers requirements that are not applicable to your Medical Device. This allows you to concentrate on the truly Essential Principles and fulfill them for several target markets in one go. When creating the reports, on the other hand, you receive a separate report for each target market, which you can submit to your Notified Bodies.
Would it be helpful if other target markets were included in the Conformity Assessment? Give us your feedback via our Roadmap Portal as to which markets would be of most interest for you.
F2304_06: BAYOOSOFT Themis meets Risk Manager
With the Technical Documentation Guide, BAYOOSOFT Themis enables you to generate the entire Technical Documentation and track the status of each individual report.
In addition, BAYOOSOFT Risk Manager guides you in a structured manner through the creation of important individual reports, such as Risk Management according to ISO 14971, Usability Engineering or Clinical Evaluation.
If you use both applications combined to create your Technical Documentation, we now offer you the option of accessing BAYOOSOFT Themis directly via an additional menu item in the Risk Manager. This gives your employees a central entry point for all aspects of Technical Documentation.
📐 Enhancements
E2304_01: Online Help for BAYOOSOFT Themis
To enable your employees getting started easily with BAYOOSOFT Themis, you now have an online help which can be reached directly from the system. In addition to the Themis 1x1, you can also access our User Guide as well as the release notes you are reading right now.
🐞 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 | 24.11.2023 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 13.12.2023 |
| 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 | 18.12.2023 |
| 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 | 19.12.2023 |
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.