risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 13.05.2008 FDA notification, CE-marking, EN 1441 Qware Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
seminars software market analysis accomodation certification notified body product lifecyclerisk management report Risk analysis of medical devices DIN EN ISO 14971
admission of medical products implementation of risk management for medical devices harmonized norm
ISO 9000 implementing of a Risk analysis risk control
post production information implementation of risk management according to DIN EN 14971
risk management versus Risk analysis documentation
seminars post production information risk management report
DIN EN ISO 14971 In-Vitro-Diagnostics CE-marking
FDA authorization CE-marking
Qware Riskmanager
product lifecycleRisk analysis of medical devices post production information
harmonized norm DIN EN 14971
accomodation certification notified body
 implementation of a risk analysis risk management normative law regulations
Likelihood and severity evaluation after measures
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003
product process severity measures evaluation likelihood
life cycle time line implement system requirements  practical application
 directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 2.5
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In-Vitro-Diagnostics IVD FDA authorization CE-marking

Frequently asked questions about Qware Riskmanager

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage  Continuative articles

When I start Qware Riskmanager the first time I have to enter an username and a password. How can I log in?


The risk analysis developed with Qware Riskmanager can contain sensitive and secret data. Therefrom the access to the system is secured by username and password. For testing purposes the following users are created:

Main program - Qware Riskmanager:
Username: sieber
Password: peter

Administration program- Qware Admin:
Username: admin
Password: admin


The delivered examples can just be viewed but I can't change anything. It seems to be read only. What did I do wrong?


In the delivery status Qware Riskmanager contains three sample projects. Every project comes with a first version. To document the atual version, the staus of this versions is freezed. So it is not possible to modify this versions. If you would like to get a version that is not freezed, you have to copy the last version in the project manager. The copy contains all data of the source version, but it can be modified without limitations.

When I create a new user in Qware Admin and I log in with this account the example projects will not be shown in the project manager. How can this be changed ?

When you log in to Qware Riskmanager, only the projects you are a member of, will be displayed in the project manager. If you would like to add the new user to the existing example projects, you have to log in as project leader (the project leader of the samples is "Peter Sieber") and authorize the user under "Risk management plan / project team".

The button"Unfreeze graph" is disabled - how can I unfreeze the graph?


Only members of the project management can unfreeze the graph. If the button "Unfreeze Graph" is disabled, it is also possible, that the version is already closed or released. This can be verified by checking the status of the checkbox "Version closed" on the page "Version data". Closed versions can not be modified any more. If the version is not already closed it is also possible that the part "Analysis and Evaluation" is freezed. Solution: Unfreeze the part "Analysis and Evaluation" on page "Decide about implementation"

On some places a red star (*) is shown in Qware Riskmanager. What is the meaning of this star?


All fields with the red star are mandatory fields, all the other fields are optional. For a successful risk analysis you have to fill out all mandatory fields.

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