risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 13.03.2010 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 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 3.0
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In-Vitro-Diagnostics IVD FDA authorization CE-marking

Riskmanagement according to DIN EN ISO 14971

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

Qware Riskmanager

the complete software solution for a successful risk management for medical devices and in-vitro-diagnostics. Qware Riskmanager was especially developed to meet the standard DIN EN ISO 14971, the fulfilment of the CE labelling and the FDA admission. The result is a well-engineered ready to work system that meets your requirements of a complete and secure risk management .

  • limit your liability as manufacturer of medical devices and in-vitro-diagnostics
  • fulfils the legal obligation for the implementation of a risk management system
  • establish audit-proof documentations with maintainable effort
  • decrease the effort of vocational adjustment about the normative requirements
  • trust in the market leader Qware Riskmanager like numerous well-known manufactors worldwide
  • also suitable for beginners

Redemption of the EN 1441 by the DIN EN ISO 14971

Since april 2004, the previous norm for the risk-analysis EN 1441 is replaced by the extensive and world wide validated norm DIN EN ISO 14971 that covers the whole process of the risk management.

Every producer of medical devices and in-vitro-diagnostics is compelled to establish the processes specified in DIN EN ISO 14971 in its company. Therefore numerous customers worldwide trust in the market leader Qware Riskmanager.

Qware Riskmanager at a glance

  • market leading product for the riskmanagement according to the DIN EN ISO 14971
  • low cost of development by relocating the costs in early phases of the life cycle of a product
  • risk management based on a configurable portfolio analysis by DIN EN ISO 14971
  • extensive, optimized report engine
  • data security by integrated rights management
  • short time of adjustment in the normative requirements of the DIN EN ISO 14971
  • legal certainty and reduction of (product-) liability via a riskmanagement that is tested by independent certification institutes all over the world
  • possibility of tracking of implemented measures over the whole product lifecycle
  • saving of labor via synergie effects of already built projects and delivered sample projects
  • alleviation of the functional analysis with the aid of a graphical illustration as grey box
  • cost-saving multilingual system

Ask for a free of charge tryout of Qware Riskmanager without any obligation. You can get Qware Riskmanager via CD-Rom or you can download the tryout version directly from this homepage.
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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