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 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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Qware Riskmanager, the software for the
risk-management according to DIN EN ISO 14971 will be continuously
enhanced. Modifications of the DIN EN ISO 14971 will be integrated
just as well as customer preferences, to provide an optimal
work equipment for our customers. Read more about
the new functions in the actual version. |
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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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| Medica 2006 |
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| Visit us at the Medica 2006 in Düsseldorf. To prevent waiting time arrange a date wit one of our consultants. |
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