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Qware® Riskmanager version history

1998: Risk 1.0
The beginning.

Risk 1.0 is the predecessor of Qware® Riskmanager. It is the first and only software solution on the market that complies with the EN 1441 standard as it is in place in 1999.

New development complying with EN ISO 14971:2000
Qware® Riskmanager is born.

Two years later, a completely new version is developed based on the experiences of the first customer projects. Importantly, it covers the amended standard EN ISO 14971:2000 through new technology and many function enhancements. This version is the first to bear the name Qware® Riskmanager and is developed as a database-driven, multi-user application.

Until 2010: version 2.0 -3.1.2
Continuous improvement.

Qware® Riskmanager, the software for risk management according to DIN EN ISO 14971, is being continuously improved and expanded. Both changes to the standard and individual customers’ requests are incorporated in order to provide you with the best possible work equipment. Users are pleased with the improved template management and the automatic spellchecker. The implementation of the knowledge database allows the use of data from already closed files. The consistently improved user interface provides users with intuitive user guidance and quick training of new employees.

2011: versions 4.0 – 4.2.5
Risikograph PHA
Qware® Riskmanager gets a fresh face.

After 12 years of continuous development, Qware® Riskmanager gets a new user interface and now supports the Microsoft SQL Server database model.
Users enjoy the first expansion module: Usability Management, which is fully integrated into the risk management process. The new Advanced Reporting module makes it possible to freely specify printer output.
In addition, FMEA is offered as an alternative method of risk analysis and this is appreciated by many clients.

2012: versions 4.5 – 4.6
The mighty knowledge base.

The ability to import a CSV file into the knowledge base enables easy maintenance of existing data within the Qware® Risk Manager, and thus a quick entry into working with the software. Users now have the possibility to copy risk analyses across products, components and processes with Qware® Riskmanager, addressing an important point for hospitals and clinics.

2012: version 4.6.1
Adaption to ISO 14971:2012

Before the ISO 14971: 2012 enters into force, Qware® Riskmanager adapts to the changes: users can perform a risk / benefit analysis according to the standard for each individual risk. Advice for the ALARP region is built into the graph definition interface. Furthermore, there is now the possibility of editing the ALARP region, which according to ISO 14971:2012 may no longer be used on the basis of financial considerations. With this change, the ALARP region in Qware® Riskmanager can edited, renamed or deleted.
Another feature of this version is the knowledge base’s auto-complete function, allowing users to re-use their knowledge from old files even faster and more efficiently.

2013: versions 5.0 – 5.4
Qware® Riskmanager offers overviews and indicates errors.

The path to complete technical documentation for medical devices is even shorter in Version 5, with two additional extension modules driving its momentum. This year Qware® Riskmanager gains the Medical Electrical Equipment module for creating compliance reports according to 60601-1, 3rd Edition, and the Essential Requirements module according to Directive IVDD 98/79/EC and MDD 93/42/EEC (2007/47/EC). The complete integration of both modules into the risk management process facilitates fast and safe production of documentation and generates huge time savings for users.
A further feature that lightens the daily workload of users of Qware® Riskmanager is the addition of dashboards to all modules. These show the current status of projects and highlight possible inconsistencies and errors.

2014: version 6
Anforderungen validieren
Efficient maintenance of product requirements in Qware® Riskmanager.

The Requirements Engineering expansion module allows product requirements to be created and linked to usability and risk management. Its dashboard shows users which requirements are currently without validation, verification, or functional coverage. It also provides an overview of features and measures which are not associated to any requirements.

2014: version 7
New basic functionality: compliance with 21 CFR Part 11.

The new basic functionalities - audit trail, digital signature and password complexity - enable compliance with 21 CFR Part 11 in the preparation of risk management files. Upon activation of the audit trail, all changes that users make to data in Qware® Riskmanager are recorded. Digitally signed documents to make it even easier for users to create technical documentation while meeting FDA requirements.

2015: version 8
Qware Riskmanager Module
Medical IT-Networks according to EN 80001-1.

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

2016: version 8.1-8.6
Optimization in usability and updates according to ICE 60601-1.

The Medical Electrical Equipment module has been updated in order to meet the requirements of IEC 60601-1. This version includes optimizations regarding the usability of the Qware® Riskmanager such as performance improvements, templates for risk graphs based on accomplished projects and the implementation of individual customers’ suggestions. Additionally, compatibility with Windows 10 has been implemented.

2018: version 9
Medical Device Classifier as additional functionality and new design.

As a product of the BAYOOMED business unit the Qware®Riskmanager is presented with a modern design in version 9. The usability- module was updated according to DIN EN 62366:2017-07. As part of these adjustments, formative and summative evaluations can now be mapped. Furthermore, the Medical Device Regulation has had its influence on the system. A Medical Device Classifier evaluates the risk category of a medical device based on simple questions. The Essential Requirements module covers basic performance and security-related requirements of the MDR and the IVDR.

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