References

Risk 1.0 is the predecessor to Qware® Riskmanager. It was the first and only software solution on the market that met the standard EN 1441 applicable in 1999.

Just two years later, the experience and insights from the first customer projects were used to develop a completely new version, which besides new technology and numerous functional extensions primarily covered the subsequent standard EN ISO 14971:2000. This version was the first to bear the name Qware® Riskmanager and was developed as a database-supported multi-user application.

Qware® Riskmanager was continuously improved and expanded as software for risk management according to DIN EN ISO 14971. It incorporated changes to the standard as well as customer wishes, thereby serving as an optimal tool.
Users appreciated the improved template management and automatic spellcheck feature. The implementation of the knowledge database enabled the use of data from already closed files. The consistently improved user interface in the software provided users with intuitive guidance, allowing new coworkers to quickly familiarize themselves with the tool.

After 12 years of ongoing development, Qware® Riskmanager received a new user interface and now supported the database model under Microsoft SQL Server. Users valued the first extension module “Usability Management”, which was fully integrated into the risk management process. The new “Advanced Reporting” module enabled the free composition of printed editions.

Moreover, FMEA was offered as another method of risk analysis – to the delight of many customers.

The CSV import feature for the knowledge database enabled easy maintenance of existing data in Qware® Riskmanager, allowing new users to quickly get started with the software. Users now had the ability to perform risk analyses for products, components and processes with Qware® Riskmanager, thereby also opening up access for hospitals and clinics.

Even before ISO 14971:2012 came into effect, Qware® Riskmanager was adjusted to the changes: Users could run a risk-benefit analysis for each individual risk in accordance with the standard. ALARP information was added to the graph definition area. What’s more, the option to edit the ALARP area was introduced, which could no longer be used for economic reasons according to the ISO 14971:2012. The ALARP area in Qware® Riskmanager could be edited, renamed or deleted with this change.
Another feature of this version was the auto-complete function in the knowledge database, enabling users to reuse information from old files even more quickly and efficiently.

The path towards complete technical documentation for medical devices gained further momentum from Version 5 with two additional extension modules. During this year, Qware® Riskmanager was expanded by the Medical Electrical Equipment module for preparing the conformity report according to 60601-1, 3rd edition as well as the Essential Requirements module according to IVDD 98/79/EC or MDD 93/42/EEC (2007/47/EC). Thanks to full integration into the risk management process, both modules enabled quick and reliable document creation as well as enormous time savings for users.
Another feature that simplified the daily work of Qware® Riskmanager users were the dashboards for all modules. They displaced the current progress for projects and indicated potential inconsistencies and errors.

The extension module Requirements Engineering allowed product requirements to be created and linked with Usability and Risk Management. The dashboard for the Requirements Engineering module showed users which requirements were currently outstanding without validation, verification and function coverage. It also offered an overview of functions and measures not assigned to any requirements at all.

The new basic functionalities Audit Trail, Digital Signature and Password Complexity enabled conformity with 21 CFR Part 11 in preparing risk management documents. When activating the Audit Trail, all changes carried out by users to data in Qware® Riskmanager were recorded. Digitally signed documents made it even easier for users to prepare technical documentation in compliance with FDA guidelines.

With the release of Version 8, users could conduct risk management for medical IT networks in accordance with EN 80001-1 in Qware® Riskmanager.

The Medical Electrical Equipment module was updated to support the requirements of IEC 60601-1, including in the new version of the standard. Additional optimizations to the usability of Qware® Riskmanager – such as performance improvements, templates for risk graphs from completed projects and other individual customer wishes – were implemented. Compatibility with Windows 10 was likewise established.

Qware® Riskmanager featured a new modern design with Version 9. The existing module for ensuring suitability for use was updated according to DIN EN 62366:2017-07. As part of these changes, formative and summative evaluations could now be covered. The Medical Device Ordinance was likewise added to the system. A medical device classifier supported the assessment of the risk class by answering simple questions. The Essential Requirements module now encompassed the fundamental performance and safety requirements of MDR and IVDR.

In addition to tracing requirements from measures as well as functions, Qware® Riskmanager now offered the option in Requirements Engineering to link requirements from different document types with each other and delivered a corresponding traceability matrix at the press of a button. At the same time, a separately installable program interface was provided as an extension module for individually configured technical implementations.

Not only does Qware® Riskmanager grow in its functional scope, BAYOONET AG also continuously expands its portfolio as a manufacturer. In addition to BAYOOMED and other business units, the software solutions Fileserver Management Suite and Qware® Riskmanager are now combined as BAYOOSOFT Access Manager and BAYOOSOFT Risk Manager under the BAYOOSOFT Management Software division.

With version 10 of the BAYOOSOFT Risk Manager, the “Clinical Evaluation” module has been integrated into the software solution. The Risk Manager supports you in the process of the same name with intuitive user guidance and complete coverage of the process phases. The solution is compliant with both the MDR and the MEDDEV 2.7.1 rev4 and thus meets the current standards.

A new extension module is now available to support the examination of the Essential Requirements for machinery according to Directive 2006/42/EC. Analogous to the functionality of the Essential Requirements module, a checklist filter allows the questions to be answered to be narrowed down. At the same time, answering the questions is fully integrated into risk management by linking, for example, hazards or measures.

With the extension modules Requirements Engineering and REST API in combination with Risk Management according to ISO 14971, BAYOOSOFT Risk Manager now offers an IEC 62304 compliant solution for the creation of technical documentation.

With version 10.3 of the BAYOOSOFT Risk Manager, more planning functions for post-market surveillance were made available. In addition, functional coverage in requirements engineering was created through interfaces in the form of the REST API. With the update of the system requirements, version 4.8 is recommended for the operation of the BAYOOSOFT Risk Manager for the SQL Server version 2017 as well as for the Microsoft .NET Framework.

With version 10.4 of the BAYOOSOFT Risk Manager, users benefit from new features such as the classifier for IVDs (in-vitro diagnostics) to determine the risk classes A to D. In addition, enhancements in the areas of risk analysis, risk assessment, measures management and residual risk assessment complement the software solution. With the update of the system requirements, version 4.8 for SQL Server Version 2017 and Microsoft .NET Framework and Microsoft Windows 8 are recommended for the operation of BAYOOSOFT Risk Manager.

With version 10.5 of BAYOOSOFT Risk Manager, users benefit from new features such as the automated import of unstructured risk management files. Furthermore, the direct addition of new elements of the analysis tree to the knowledge base is now possible, as well as the visualization of existing traces between elements. In addition, the enhancements “Extended template management” for the entire Risk Manager and the “Multi-user function” for the entire “Clinical evaluation” module are available.

BAYOOSOFT Themis opens a new chapter in technical documentation. As the first available module, the Documentation Guide belongs to the next generation of systems for validated solutions around documentation processes of medical devices and in-vitro diagnostics. It offers all the basic functions of the Risk Manager, but can be installed as a desktop app or used in the web interface regardless of location and device.