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 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- 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

Version history Qware Riskmanager

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

New in QWare Riskmanager 4.0

Overview of the changes:

  • Completely new developed
  • Support for Microsoft SQL Server 2008
  • Usability Engineering Files according to DIN EN 62366
  • Failure Mode and Effects Analysis (FMEA) according to DIN EN 60812 and IEC 60812
  • Simultaneous multi user access
  • Individual customizable reports

At Medica 2011 we are pleased to present the new version 4.0 of Qware Riskmanager which was continuously developed from scratch over a time period of 12 years. The Risk Manager is the world's leading software product for risk management according to DIN EN 14971.

User Interface Design GmbH In cooperation with the User Interface Design GmbH, the Riskmanager has been extended to the usability engineering in accordance with IEC EN 60601-1-6/EN62366 In addition to that Riskmanager 4.0 supports not only the classical risk analysis but also the FMEA according to DIN EN 60812 now.

Parallel to the implementation of the in previous versions already available known and proven risk management process, in version 4.0 FMEA according to DIN EN 60812 and IEC 60 812 was integrated as an additional tool in Riskmanager. Thus the user can decide from case to case, which tool for its specific application seems more appropriate.

In addition to the numerous other technical and functional innovations, the redesigned user interface in particular leapt to the eye. In spite of the extensive innovations in the context of continuous software maintenance, the structure of Qware Riskmanager has been continuously designed at the logical end to the underlying norm DIN EN ISO 14971 This ensures a short learning curve for users who are already familiar with the previous versions.

An extended license model allows in the future adapting the license adjusted to the needs of the user. In addition to the basic module which reflects the enhanced functionality of its previous versions, the functionality for creating Usability Engineering Files will be available within the scope of the additional usability module. The additional Advanced Reporting module which allows free design of print editions offers for demanding users completely new design possibilities for the company-specific customization and expansion of all documents.

Get an idea of the completely revised version 4.0 and visit us at Medica, the world's largest event for the medical industry. There you can discuss with our experts all new features within a fully functioning and with many sample data staffed environment. Get familiar with the software and its new benefits, convince yourself of the functionality and ease of use and get also free advice on how to improve the accreditation process under the CE-labeling in your company.

Make a preliminary appointment

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
Register for a preliminary appointment with our experts at Medica 2011.
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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
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about the Qware Risk-
manager as download:
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Trial Version
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