risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 01.08.2010 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
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 3.0
In-Vitro-Diagnostics IVD FDA authorization CE-marking

IMPRINT

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage Qware Riskmanager 3.0

Qware Riskmanager is a produkt of bayoonet AG, germany.


Publisher:

bayoonet Aktiengesellschaft
Robert-Bosch-Strasse 7
D-64293 Darmstadt
Germany

Phone: +49 (0) 6151 - 87 01 05 - 0
Fax: +49 (0) 6151 - 87 01 05 - 50
info@bayoo.net
http://www.bayoo.net

Chairman of supervisory board:

Rainer Wieshoff

Managing board:

Dipl.-wirtsch.-Ing. Frank Manger (President of the Board)
Dipl.-wirtsch.-Ing. Stefan Becher

bayoonet AG is registered in the commercial register of the Amtsgericht (local court) Darmstadt under the number HRB 8374

The VAT registration number of bayoonet AG is: DE219068012

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The market leading software solution for the riskmanagement of medical devices and in-vitro-diagnostics is completely revised. Read more about the new functions.
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