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Version history

Qware® Riskmanager version history

21 dec.

Start

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.

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.

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
QwareRiskmanager150
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
MEE-Checklisten-Filter
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: versions 8 and 9
Qware Riskmanager Module
EN 80001-1 and IEC 62304

With the release of Version 8, Qware® Riskmanager users can perform risk management for medical IT networks in accordance with EN 80001-1. The next version of Qware® Riskmanager will offer another expansion module: the life cycle of medical equipment software according to IEC 62304.

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