Language:
 

Virtual Tour

For 16 years, Qware® Riskmanager has been the world’s leading software solution for creating technical documentation for manufacturers of medical equipment and in-vitro diagnostic devices.
Qware® Riskmanager is a software application that leads you in a structured way through standards requirements, and illustrated with provided examples. The self-learning knowledge base already integrated in the basic module automatically proposes intelligent suggestions in appropriate places. In this way, live and fully automatically as you enter text, the application analyzes every document ever created by your company in Qware® Riskmanager and detects whether other, similar products previously had entries which you might not have thought of for the current project: other hazards, or identified sources of risk, or implemented measures. In addition, Qware® Riskmanager’s efficiency calculator determines for example what measures could be particularly efficient and suggests these accordingly.
Below you will find a short virtual tour of the software. We will gladly give you a free, non-binding, online presentation on Qware® Riskmanager. Please also download the free trial version of Qware® Riskmanager and see for yourself how Qware® Riskmanager can accelerate and simplify approval processes: you spend your time on content, not on form.

Headline:

Choices for the risk analysis procedure

  • Definition-Risikograph
  • Risikograph PHA
  • FMEA Definition

Qware® Riskmanager offers the choice of two methods of risk analysis: FMEA (Failure Mode and Effects Analysis, according to DIN EN IEC 60812) and PHA (Preliminary Hazard Analysis). In both cases, you can define global risk templates or set risk definitions individually for each project or even for each version of a project. In the pictures you can see an example of a risk graph conforming to ISO 14971: 2012 based on the PHA method as well as the risk graph and FMEA definition areas.

Headline:

Automatic checking of technical documentation

  • Dashboard Risikomanagement
  • Dashboard Grundlegende Anforderungen
  • Dashboard Grundlegende Anforderungen
  • Dashboard Usability Engineering
  • Dashboard Medical Electrical Equipment

On opening Qware® Riskmanager, existing technical documentation is fully automatically analyzed and checked for formal errors. The results of the analysis are clearly summarized in the dashboards. Hence you see at a glance where your documentation has inconsistent data or is incomplete. In this manner Qware® Riskmanager checks, for example, whether all applicable requirements were met, such as the essential requirements set out in the Medical Devices Act or the requirements for electrical medical devices in accordance with IEC 60601-1 Third Edition. In addition, logical conditions are checked – e.g. whether a risk was reduced without performing a measure that might reduce the risk in question, if unrated risks exist, or if requirements have not been validated or functionally covered. The results are then displayed clearly in the dashboards.

Headline:

Gathering requirements (requirements engineering)

  • Anforderungen erfassen
  • Anforderungen validieren

The management of requirements is of great importance especially for complex products and systems, and their development through division of labor. In the field of medicine, this is not just about reaching a common understanding between the various parties, but it must be completely ensured that the requirements are implemented and accordingly validated. If it so happens that, in the course of a risk assessment, after the implementation of a requirement, a new risk emerges or existing risks change, then it must be ensured that this likewise results in a requirement. Qware® Riskmanager fully integrates requirements engineering in the regulatory processes to be followed by manufacturers of medical devices. Thus new requirements can automatically be created out of measures, there is a direct link between requirements and resulting functions, and there is a validation and verification which in addition distinguishes between general and usability requirements.

Headline:

Setting up risk analysis

  • Risikoanalyse PHA
  • Risikoanalyse FMEA
  • Automatische Vorschläge Wissensdatenbank
  • Import aus anderen Projekten
  • Suchen Ersetzen

A central component of Qware® Riskmanager is the risk management tree. In Preliminary Hazard Analysis (PHA), this where functions, hazards, sources, and measures are gathered.
In FMEA, it where the functions, manners of failure, effects of failure, causes of failure, and the current and recommended measures are found. To create the risk analysis, you can build on your existing knowledge, importing or copying part of the tree or an entire risk analysis, or build up the analysis interactively with the knowledge base. Furthermore, there are powerful tools such as a content-based search and replace function, which, in contrast to other applications such as Office, ensures that a desired substitution is not inadvertently also applied in an measure elsewhere in your documentation, for example.

Headline:

Assessing risk and selection of measures

  • Bewertung-PHA
  • Bewertung-Graph-PHA
  • Bewertung-Massnahmen-Durchfuehren-PHA
  • FMEA-Bewertung
  • FMEA-RPZ-Verteilung-Anzeigen
  • FMEA-Durchführung-Entscheiden

Depending on the selected process model (FMEA or PHA), the assessment of the risks happens at the cause layer or by the combination of failure mode, failure effect and cause of failure, respectively. The risk graph or FMEA diagram is updated as you type, so you can immediately see the current assessment status of each measure up to the complete component, product or process. Qware® Riskmanager automatically calculates the level of efficiency of the risk-reducing measures which you have implemented and lists the results in an overview. Hence you can see at a glance which measures would reduce several risks at once or which measures reduce risks that are not in an acceptable range, for example. The choice of measures is made by a single mouse click, which starts the measure management process.

Headline:

Creation of a risk management plan

  • Risikomanagementplan-Versionsdaten
  • Risikomanagementplan-Projektteam
  • Risikomanagementplan-Verknüpfte-Versionen
  • Risikomanagementplan-Graph-Definieren
  • Risikomanagementplan-Freigabekriterien
  • Risikomanagementplan-Mitgeltende-Unterlagen
  • Greybox

In order to construct a product portfolio and traceability requirements, Qware® Riskmanager offers the possibility of fine-grained project and version management. Here you can collate general information such as purpose, potential misuse, conditions of intended use, medical indication, the physical operation, and appropriate lifecycle phase. You can define risk graphs or FMEA catalogs, indicate further applicable documents such as your QM manuals and procedures, and store approval criteria for risk acceptance, review plans, or procedures for demonstrating the effectiveness of risk management.
For complex projects, product groups or families of products, or frequently used components, the integrated overall structure plan provides a shortcut to efficient processing of your technical documentation.
Qware® Riskmanager’s Greybox module provides you with the functionality of an electronic whiteboard. In conjunction with Lifesync Technology, you can brainstorm in real time with colleagues in different geographic locations, or create a workflow or a product sketch that aids you in detecting risks and selecting risk-reducing measures.

Headline:

Definition of the project team

  • Risikomanagementplan-Projektteam
  • Admin-Benutzerverwaltung
  • Admin-Rollenverwaltung

Qware® Riskmanager possesses an audit-secure, fine-grained permission system. Within a single administration interface, users can be created and roles defined. By assigning users to roles, the standard permissions can be used to create security concepts without extra configuration, which can be transferred between projects. Possible permissions include definition of graphs, performing analysis, evaluation, approval of measures and decision on their implementation and subsequent validation, re-evaluation, post-market observation, or determination, validation, or verification of measures.
Furthermore, each version has the possibility of overwriting the permissions for each individual team member. This authorization model allows you to be sure that only authorized persons have access to your data, and you can also verify the implementation in an audit-safe way.

Headline:

Measure management

  • Massnahmenmanagement-Details
  • Massnahmenmanagement-Freigabekriterien
  • Massnahmen-Controlling
  • Bewertung-Massnahmen-Durchfuehren-PHA
  • Massnahmen-Neubewertung

A central part of technical documentation is the process of measure management, which is covered by Qware® Riskmanager in a fully integrated way.
Qware® Riskmanager automatically calculates the level of efficiency of the risk-reducing measures which you have implemented and lists the results in an overview. Hence you can see at a glance which measures would reduce several risks at once or which measures reduce risks that are not in an acceptable range, for example. The choice of measures is made by a single mouse click, which starts the measure management process.
For each selected measure, you can then define responsibilities (for implementation and for monitoring), assemble implementation teams, indicate schedule and cost plans, and define individual approval criteria, such as for procedures for demonstrating the effectiveness of the measures, or procedures for verification and validation as well as their respective acceptance ranges. On the “Controlling” tab you have an up-to-date overview at all times of the implementation status of all finalized measures.
When reassessing risks, Qware® Riskmanager checks whether risks have been reduced without the implementation of any specific risk-reducing measures, and alerts the user to these potential errors. Should any new hazards arise from implemented measures, connections within Qware® Riskmanager are created. The process can be made consistent by the press of a button, which automatically generates new requirements from finalized measures.

Headline:

Reassessment

  • Neubewertung-Vorher-Nachher
  • FMEA-Vorher-Nachher
  • Massnahmen-Neubewertung

Reassessment of risks is carried out as part of a re-evaluation after the implementation of measures. The risk graph shows the areas in which risks remain and the user can directly view the risk reduction effectiveness in the Before/After overview. Interactive functions guide the user directly to the issues which do not meet the required acceptance criteria, and also with the aid of suggestions from the self-learning knowledge base, a further reduction in risk can be achieved. Automatic checks support the user in the evaluation and re-evaluation of all risks, and help to avoid errors in assessment.

Headline:

Essential requirements in accordance with MDD 93/42/EEC and IVDD 98/79/EC

  • Grundlegende-Anforderungen-Checkliste
  • Grundlegende-Anforderungen-Massnahmen

In Europe, medical devices may only be put on the market or put into service if they are provided with a CE mark. Medical devices may be provided with a CE mark only if the essential requirements are met and the conformity assessment procedure prescribed for the particular medical device has been carried out. For in-vitro diagnostic devices, the essential requirements are the requirements of Annex I to Directive 98/79/EC, and for other medical equipment, the essential requirements are the requirements of Annex I to Directive 93/42/EEC.
Qware® Riskmanager possesses an "Essential Requirements" module that, with the help of an interactive checklist, picks out the questions which you must answer in order to fulfil the essential requirements laid down in MDD 98/79/EC and IVDD 93/42/EEC. Through automatically answering questions which are not applicable and full integration into existing risk management, the processing time is noticeably reduced. It is not necessary to create a new risk assessment to meet the essential requirements - instead, existing data for risk management in accordance with ISO 14971 can be used. Labor is saved, inconsistent risk assessments are excluded, and your technical documentation is at all points at an identical state of evaluation.

Headline:

Checking usability (usability engineering)

  • usabilitymanagement-anforderungen
  • usabilitymanagement-beabsichtigte-patientengruppe
  • usabilitymanagement-benutzungsszenarien
  • usabilitymanagement-design-implementierung
  • usabilitymanagement-nutzergruppen
  • usabilitymanagement-validierungsplan
  • usabilitymanagement-validierung
  • usabilitymanagement-verifizierung

Standard DIN EN 62366 requires manufacturers of medical equipment to perform a usability engineering process and to document it in a usability engineering file.
The usability engineering process is not just about meeting legal requirements. Usability is increasingly becoming a key selling point. Implementation of usability measures reduces the risk of errors in operation for users, patients and third parties. Moreover, since representative users are already involved in the development process, a high acceptance of the product in the target group is assured.
Qware® Riskmanager fully integrates the usability engineering process into risk management according to ISO 14971 and takes you through it step by step with a proven macrostructure for a usability engineering file in accordance with DIN EN 62366 and IEC EN 60601-1-6.
From intended conditions for use on medical grounds, indicated patient and user groups, usage scenarios, main operations and requirements, to validation plans and verification (e.g. by usability tests, focus groups, expert reviews or cognitive walkthroughs) - Qware® Riskmanager completely covers all aspects of IEC EN 60601-1-6 and EN 62366 and accelerates your workflow significantly.

Headline:

Compliance reports for medical electrical devices

  • MEE-Checklisten-Filter
  • MEE-Anforderungen
  • MEE-Prüfprotokoll
  • MEE-Insulation-Diagram

One of the most important aspects of the 3rd edition of IEC EN 60601-1 is the inclusion of risk management processes in accordance with ISO 14971. In addition to this complex challenge, more than 1,500 tests have to be considered for applicability and to be audited with test protocols.
Qware® Riskmanager simplifies this process significantly and creates the full compliance report in accordance with IEC 60601-1. Duplicate registrations are completely eliminated, and irrelevant checks are automatically filtered out by intelligent queries. You are interactively guided through the entire standardization process.
Risk management processes in accordance with ISO 14971 are fully integrated, so you can use your existing reviews and analysis and changes need be made only to a single central point.
Qware® Riskmanager is licensed by the IEC.

Headline:

Version comparison

  • Versionsvergleich1
  • Versionsvergleich2

Qware® Riskmanager meets the requirements of FDA Part 11 and records every change in an audit log. In addition, the version comparison function generates a difference report between freely chosen versions of a project so that, for example, after returning from an absence, you can see at a glance which changes were made and where they were made in your technical documentation. The report can be saved and exported in various formats such as PDF.

Headline:

Automatic generation of technical documentation

  • Dokumentation-Deckblatt
  • Dokumentation-Freigabeprotokolle
  • Dokumentation-Massnahme
  • Dokumentation-MEE2
  • Dokumentation-Anforderungen
  • Dokumentation-Risikographen
  • Dokumentation-Usability1
  • Dokumentation-Usability3
  • Berichtszusammenstellung
  • Dokumentation-Einstelluingen

The full technical documentation or any selected subset can be generated at any time by pressing a button. Available export formats include PDF, Microsoft Word, Microsoft Excel, HTML, and XML, as well as other formats. Of course, it is possible to print the documents directly in A4 or US Letter.
An interactive preview of the generated documents can be viewed before exporting/printing. The table of contents and consecutive page numbers are automatically generated. Advanced settings allow the inclusion of own logos, the use of global document numbers or report titles, and numerous options for integrating signature strips. The watermark function enables text to be embedded in the background of all documents, such as "DRAFT". This should prevent outdated documents or those not yet finalized being sent to Notified Bodies.
Standard selections offer popular document configurations, but you can create and save your own configurations, and set any as the default choice. Thus your favorite configurations can be quickly and easily applied.

Headline:

Post-market observation

  • Marktbeobachtung-Reminder
  • Marktbeobachtung

If you are a manufacturer of medical devices, you are, under the appropriate European medical product law, subject to a vigilance system that encompasses all levels of post-market observation of the medical devices which you have put on the market. This includes the monitoring and assessment of all incidents and corresponding hazard controls, such as callbacks. Qware® Riskmanager has its own post-market observation area which allows you to document your monitoring. If in the course of market monitoring it is discovered that a new risk assessment is necessary, this can also be documented. With the integrated reminder system, you can use Qware® Riskmanager to create reminders in Microsoft Outlook or Lotus Notes, so that you are reminded of regular post-market observation of corresponding products.

Headline:

Administration

  • Admin-Projektverwaltung
  • Admin-Wissensdatenbank
  • Admin-Prozessarten
  • Admin-Testbeschreibungen
  • Admin-Anforderungsvorlagen
  • Admin-Musterdefinition
  • Admin-Dokumentationseinstellungen

Qware® Riskmanager has a dedicated administration area. Here backups can be created or imported, risk graph templates or FMEA catalogs can be defined, or descriptions of test methods can be created or modified. There are many ways to import existing knowledge into the knowledge base and to edit it, and manage master data and standard templates. Since each company has its own quality management manual, the sample tests can be adapted, e.g. how a project, version, hazard, or measure reference number is constructed and what degrees of freedom users have here for their actions.

Headline:

Advanced Reporting

  • Advanced-Reporting
  • Admin-Advanced-Reporting

More than 70 different output reports are available with the base and expansion modules, which can be also combined with each other and individually adjusted via setting options. The development of reporting formats has incorporated more than 15 years of experience with product approvals from customers and Notified Bodies from around the world, as well as thousands of product files. By adopting Qware® Riskmanager, you can be sure that the report is correctly formatted and you can concentrate solely on the contents. Nevertheless, there are for example customers who, due to specific corporate identity guidelines, still have individual specifications for various formatting options: e.g. spacing between logos and text, or which fonts to use. The Advanced Reporting module provides you with full freedom to access existing reports, to customize them or to re-create them. Alternatively there is also the possibility to have the Customizing Service customize reports at a favorable rate.

Anmeldung

Forgot password?

If you forgot your credentials, please click here to request new ones.