Qware Risk Manager
| Qware Risk Manager
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| Basic data
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| developer | bayoonet AG |
| Current version | 9 (2018) |
| operating system | Microsoft Windows |
| License | proprietary |
| German speaking | Yes |
| http://www.risk-online.de | |
Qware Riskmanager is a commercial software product from the software company BAYOONET AG and the most frequently used application program in the world to implement the risk management process and to meet the requirements of the international ISO 14971 standard . It is available for Windows operating systems.
Features and special features
The first version of the Qware Riskmanager appeared in 1997 and has been adapted since then according to the specifications of the manufacturers of medical products working with the software and the notified bodies responsible for the CE marking of the products . According to users, the advantage is that the software guarantees compliance with the normative requirements and only the specific product details need to be entered in the processing masks.
Every manufacturer of medical devices and in-vitro diagnostics is obliged to introduce the processes described in ISO 14971 in-house and apply them to risk management. The normative requirements must be strictly observed. Qware Riskmanager generates the risk management file in a form that is accepted by the approval bodies and the responsible authorities.
Due to the structure of the software and the integrated versioning and authentication, the traceability required by the standards can be guaranteed, which cannot usually be mapped through the use of non-standard-specific documentation systems such as Microsoft Excel or Microsoft Word.