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 lifecycle risk 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
ISO 9000 implementing of a Risk analysis risk control
post production information implementation of risk management according to DIN EN 14971- Medica 2011
post production information implementation of risk management according to DIN EN 14971- Advantages
risk management versus Risk analysis documentation- Screenshots
seminars post production information risk management report- Trial Version
DIN EN ISO 14971 In-Vitro-Diagnostics CE-marking- Full version
FDA authorization CE-marking- Download
Qware Riskmanager- Purchase
product lifecycleRisk analysis of medical devices post production information- FAQ
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
New functions in Qware Riskmanager 4.0
Visit us at the Medica 2011
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Purchase Qware Riskmanager - Software for risk management

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage Medica 2011

Price list

Con-
current
User*		 Basic module
Riskmanager

 Expansion module Usability Engineering Expansion module Advanced Reporting**
1   2.780,00 €   1.780,00 € 10.000,00 €
3   5.580,00 €   3.380,00 € 10.000,00 €
5   8.380,00 €   4.980,00 € 12.580,00 €
7   9.780,00 €   5.380,00 € 14.680,00 €
10 11.180,00 €   5.580,00 € 16.780,00 €
25 26.580,00 € 13.280,00 € 39.880,00 €
50 48.980,00 € 24.480,00 € 73.480,00 €

The purchase price comprises the unlimited right of use under the terms of the licence agreement and in addition all software updates and all new versions for a period of 12 months. The stated prices are quoted plus legal VAT, postage and package.

Orders

Orders of the full version of Qware Riskmanager should be sent via fax or via mail to the following fax number or postal address:

bayoonet AG

Order management
Robert-Bosch-Str. 7
D-64293 Darmstadt
Germany

Fax: +49 (0) 6151 - 87 01 05 - 50

Alternatively you can download an order-form and send it as fax as well.

Terms of payment

Customers in Germany, Austria and Switzerland can order by invoice, payable within 7 days without any discount. Delivery in foreign countries only against prepayment or cash on delivery.

Shipping costs

Inside the European union there are no additional shipping costs. The actual flat rates for deliveries outside the European union will be send on demand.
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Qware Riskmanager 4.0
Qware Riskmanager 4.0
The market leading software solution for the riskmanagement of medical devices and in-vitro-diagnostics is completely revised.
Read more about the new functions of Qware Riskmanager 4.0
Downloads
Further information
about the Qware Risk-
manager as download:
References
Trial Version
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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