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 normQware Riskmanager
ISO 9000 implementing of a Risk analysis risk control
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- Tryout
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 2.5
Visit us at the Medica 2006 Visit us at the Würzburger Medizintechnik Kongress fbmt 2007
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Full version Qware Riskmanager - risk management DIN 14971

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage   Advantages at a glance

Differences to the tryout version

The tryout of Qware Riskmanager already features all necessary functions to build and edit risk management projects agreeable to
ISO 14971. Just the functions to print the risk management dossier and to export the reports in different formats (PDF, XLS, RTF, etc.) is restricted.
With purchasing the full version you will get a license-key that activates all functions in Qware Riskmanager. If desired, all data entered in the tryout version can be imported in the full version as well.

License modell

All versions of Qware Riskmanager can be installed on as many clients as wanted, as long as all clients use the same server database. Dependent on the number of licensed users, the software allows the simultaneous access off one, three ore more users.

Price list

Tryout free
Single user license EUR 1.980,00
Network license (up to 3 User simultaneous) EUR 3.980,00
Network license (up to 10 User simultaneous) EUR 7.980,00
Open License on demand

The purchase price comprises the unlimited right of use under the terms of the licence agreement and in addition all software updates , all new versions and technical support via our call center 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.
Screenshots Qware Riskmanager
Continuative articles
Risk management – Use legal obligations for the advantage of your company.
Risk management for medical devices and in-vitro-diagnostics in laws, regulations and standardisation.
Risk management accompanying the development of products and methods saves you time and costs.
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.
Medica 2006
Medica 2006 Düsseldorf
Visit us at the Medica 2006 in Düsseldorf. To prevent waiting time arrange a date wit one of our consultants.
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