risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 19.05.2012 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 normQware Riskmanager
harmonized norm DIN EN 14971
accomodation certification notified bodyReferences
implementation of a risk analysis risk management normative law regulations
Likelihood and severity evaluation after measuresPartner
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003Articles | Reports | News
product process severity measures evaluation likelihood
life cycle time line implement system requirements practical applicationService
directive 93/42/EWG risk evaluation and for risk control
post production information implementation of risk management according to DIN EN 14971- Support & Updates
risk management versus Risk analysis documentation- Download Updates
seminars post production information risk management report- Trainings
directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 4.0
Visit us at the Medica 2011
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Support & Updates

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

Support

Most of the questions and problems with the Qware Riskmanger
can be solved by reading the embedded online-help function. You can use the online-help by pressing the "F1" button on your keyboard while the Qware Riskmanager is running.
Additionally, you can have a look at our frequently asked questions
on this website.

For further questions you can contact us directly via E-Mail (support@bayoo.net) or by phone (+49 (0) 6151 - 87 01 05 - 0).

Updates

To adapt Qware Riskmanager to future technical and legal requirements, the software is continually being improved.
Registered users with a valid update contract can download the latest updates and patches from this website under the menu topic "Service / Download Updates". New customers get an update contract for all software updates, all new versions and technical support via our call centre for a period of 12 months for free.

Update contract

Users of the Qware Riskmanager can ensure their investment in the market leading software solution for risk management according to DIN EN ISO 14971 by placing an update contract. Thus you will be one of the first to benefit from software enhancements. For just 18% of your current license fee, you can extend your free update contract for further 12 months.

Screenshots Qware Riskmanager
Here you get an overview of frequently asked questions. Please check this site first, before you start a request for support.
Partner
Screenshots Qware Riskmanager
Here you find the appropriate partner to implement your risk management system.
References
Screenshots Qware Riskmanager
Here you get an overview which companies already use Qware Riskmanager the market leading software for risk management according to DIN EN ISO 14971, IEC EN 60601-1-6 and DIN EN 62366.
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