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Training and workshops

User training / Risk management workshops

Complementary to our product Qware® Riskmanager, we also organize training in the use of our software and workshops on risk management in accordance with ISO 14971.

Open user training for "Qware® Riskmanager" (beginners)

Course contents:

  • Welcome and introductions
  • Structure and layout of Qware® Riskmanager
  • Menu items and structuring of data
  • Concept of authorization with roles and rights
  • Implementation of risk management processes in accordance with DIN EN ISO 14971 in Qware® Riskmanager
  • Implementation of FMEA in Qware® Riskmanager
  • Implementation of usability management (IEC 60601-1-6 / EN 62366) in Qware® Riskmanager
  • Compliance reporting in accordance with IEC 60601-1, 3rd edition in Qware® Riskmanager
  • Summary
  • Brief overview of Advanced Reporting module
  • Setup/Installation/Technical requirements
  • Outlook

Organizational details

The venue is Robert-Bosch-Str. 7, 64293 Darmstadt.
There is a minimum of 3 and maximum of 10 participants.
The training costs amount to 590.00 EURO plus VAT. Drinks and training materials are provided by BAYOONET AG.
Please send your participation request via e-mail to sales@bayoo.net. You will promptly receive the (binding) registration forms. Cancelling a resignation is free of charge up until 4 weeks before the training date, thereafter 30% of the participation fee will be due. If cancelling less than 1 week before the booked training date, 80% of the participation fee will be due. The training language is German. Information regarding expert training or training in English is available on request.
It is recommended that you please bring your own laptop, with the most recent version of Qware® Riskmanager installed (the trial version is sufficient).

Software training for users and administrators

The software training depends on how much prior knowledge the participants on the day have. The event room and equipment (video projector and flip chart) are provided by the client. To successfully train the participants, it is advantageous if the client provides a sufficient number of PC workstations with Qware® Riskmanager installed for the participants for the practical part. Possible topics covered include:

  • Structure and layout of Qware® Riskmanager
  • Menu items and structuring of data
  • Data model / database
  • Project overview
  • Concept of authorization with roles and rights
  • Project types (FMEA, classic risk analysis, usability engineering, medical electrical equipment)
  • Implementation of risk management processes in accordance with DIN EN ISO 14971 in Qware® Riskmanager
  • Implementation of FMEA in Qware® Riskmanager
  • Implementation of usability management (IEC 60601-1-6 / EN 62366) in Qware® Riskmanager
  • Creating compliance reports in accordance with IEC 60601-1, 3rd edition in Qware® Riskmanager
  • Introduction to the practice of risk analysis, working through an example project with the course participants
  • Risk management plans and risk management teams
  • Defining templates and graphs
  • The grey box model
  • Analysis
  • Assessment
  • Measure management
  • Reassessment and residual risk
  • Documentation
  • Post-market monitoring and versioning
  • FMEA
  • Usability engineering
  • Creating compliance reports in accordance with IEC 60601-1 with the MEE-module
  • Summary

Risk management workshop for risk management processes in accordance with DIN EN ISO 14971 including introduction to risk management documentation with Qware® Riskmanager

The content of risk management workshops can be adapted and designed according to your wishes. The goal here is to provide a regulatory overview, as well as basic training in working with Qware® Riskmanager. The workshops are usually divided into alternating training days followed by normal working days with our experts available for advice. These latter days are used to create the actual risk management files for your own products in accordance with DIN EN ISO 14971.
The scope and content of a risk management workshop is planned according to the desires of the individual client. The following is a representative example of the structure of a workshop:

  • Introduction to the Medical Devices Act: What is a medical device - which is a system and what is a combination?
  • The philosophy of the directive: The concept of safety Relationships between post-market observation and vigilance systems for medical devices, complaint handling, and risk management
  • Harmonized standards for risk management: ISO 14971
  • Requirements of ISO 14971 and the MDD for instruction manuals and technical documentation
  • Product development models
  • Risk management as a tool supporting product development
  • Introduction to using Qware® Riskmanager and working through the risk analysis for an example productStructure and layout of the Qware® Riskmanager
  • Menu items and structuring of data
  • Data model / database
  • Project overview
  • Concept of authorization with roles and rights
  • Project types (FMEA, classic risk analysis, usability engineering, medical electrical equipment)
  • Implementation of risk management processes in accordance with DIN EN ISO 14971 in Qware® Riskmanager
  • Implementation of FMEA in Qware® Riskmanager
  • Implementation of usability management (IEC 60601-1-6 / EN 62366) in Qware® Riskmanager
  • Creating compliance reports in accordance with IEC 60601-1, 3rd edition in Qware® Riskmanager
  • Introduction to the practice of risk analysis, working through an example project with the course participants
  • Risk management plans and risk management teams
  • Defining templates and graphs
  • The grey box model
  • Analysis
  • Assessment
  • Measure management
  • Reassessment and residual risk
  • Documentation
  • Post-market monitoring and versioning
  • Closing discussion
  • Summary

This event, which has a high proportion hands-on activity, is held at your place of business. Depending on your field of activity and your needs, we will prepare a two-day or multi-day workshop and the appropriate training materials. We are happy to create a customized package for you.

 

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