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 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
In-Vitro-Diagnostics IVD FDA authorization CE-marking

New in Qware Riskmanager 3.0

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

New functions in Qware Riskmanager 3.0

Qware Riskmanager, the software for the risk-management according to DIN EN ISO 14971 will be continuously enhanced. Modifications of the DIN EN ISO 14971 will be integrated just as well as customer preferences, to provide an optimal work equipment for our customers.

Subsequent you get an overview of some functions that were enhanced or added in the current version:

  • Delta comparison of two riskmanagement versions
  • Optional read-only access to locked versions
  • Template-based administration of the graph
  • Explicit management of new hazards deriving from the implementation of measures
  • Copy of portions of the tree to other versions and projects
  • Improved Risk Control
  • Revised greybox with improved operating functions
  • Color-coding of the implementation status of measures
  • Add scenario information to functions
  • Automatic login (single sign-on)
  • Automated generation of mindmaps
  • Improved opening and closing of the risk tree
  • Additional reports



New functions in Qware Riskmanager 2.5


Subsequent you get an overview of some functions that were enhanced or added in version 2.5. Of course these functions are also available in version 3.0:

  • Flexible version number management
  • Spell check
  • New reporting engine
  • Automatically generated suggestion lists
  • Extended user administration
  • Improved risk control
  • Draft output
  • PDF-export of the risk management documentation
  • Hyperlinks to external documents
  • Residual risk & residual risk evaluation
  • Renaming of product types
  • Improved user interface
  • Tremendous number of detail improvements



New functions in Qware Riskmanager 2.0


Subsequent you get an overview of some functions that were enhanced or added in version 2.0. Of course these functions are also available in version 2.5 and 3.0:

  • dynamical adjustment to the screen resolution in the range between 800x600-1600x1200 pixel
  • enhanced Project Manager now with directselection-buttons
  • copy&paste-function in the riskmanagement tree
  • enhanced measure management with option to show dependencies
  • search&replace-function in the riskmanagement tree
  • context sensitive help-function
  • universally improved user interface
  • integrated hyperlinks to files on the network or internet
  • completly revised user administration in Qware Admin
  • clearly arranged riskmanagement documentation
  • improved project&version administration in Qware Admin
  • optimized handling of the lists of functions, hazards, causes and measures in Qware Admin
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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manager as download:
References
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