Legal certainty
Qware® Riskmanager minimizes the expenditure for the fulfilment of legal precondition
according to the law of medical devices, for the CE labelling and the FDA admission.
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- grants you the security of a validated and acknowledged
method of risk management according to the DIN EN ISO
14971
- comes with an intuitional user guidance through which
you take automatically the right steps - without the need
of initial skill adaptation training
- Qware Riskmanager generates the required documentation
of your results which is accepted by the admission offices
and the appropriate authority
- contains anintegrated project and version management
through which your risk management becomes comprehensible
and your measures can be backtracked
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Strategic advantages
Qware Riskmanager offers an efficient control of the exertion of
your resources in development
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- estimates relevant product risks at an early stage of
product development through systematic risk management
which give you the possibility to initiate counteractive
measures and abbreviate development cycles
- provides all favoured information e.g. cognizances,
criterias for evaluation, measures and status of the work
at all time
- assures for you the implementation of all decided arrangements
through an integrated management of measures
- documents and uses your experiences and knowledge through
expandable lists for functions, hazards, causes and measures
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Efficiency and economies
Qware® Riskmanager simplifies the
introduction, accomplishment and documentation of the risk management
according to DIN EN ISO 14971, IEC EN 60601-1-6 and DIN EN 62366 and supports you efficiently
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- reaches the acceptance of your employees through its
special clearness, simple handling and clear user guidance
- ensures even in highly complex projects a clear overview
by its intelligent structured construction and the possible
referencings
- alleviation of the functional analysis with the aid
of a graphical illustration as grey box
- automatic generation of the list of all single measures
with all associated hazards, causes and functions
- optional integration of company specific product types
and project-oriented definitions saves work and time
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Register for a preliminary appointment with our experts at Medica 2011. |
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 Make an appointment |
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Qware Riskmanager 4.0 |
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The market leading software solution for the riskmanagement of medical devices
and in-vitro-diagnostics is completely revised. |
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Read more about the new functions of Qware Riskmanager 4.0 |
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Continuative articles |
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Risk management – Use legal obligations
for the advantage of your company. |
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Risk management for medical devices and in-vitro-diagnostics in laws, regulations and standardisation |
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Risk management accompanying the development of products and methods saves you time and costs |
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