risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 08.09.2010 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
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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
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directive 93/42/EWG risk evaluation and for risk control
post production information implementation of risk management according to DIN EN 14971- Support & Updates
risk management versus Risk analysis documentation- Download Updates
seminars post production information risk management report- Trainings
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

Trainings for risk management according to DIN EN ISO 14971

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User trainings / risk management workshops

In addition to our software product Qware Riskmanager we offer user trainings and risk management workshops according to ISO 14971. From software trainings for engineers up to complex workshops to develop a complete risk management for your products, bayoonet will support you state-of-the-art with top-skilled consultants.

Software training for users and administrators

The software training takes a half day to a whole day depending on the precognition of the course participants. The course will take place in your company. Abstract of the course content:

  • logical configuration and structure of Qware Riskmanager
  • Qware Riskmanager at a glance
  • best practice recommendations
  • live-demonstration
  • working with Qware Riskmanager
  • central administration tasks with Qware Admin
  • answering of user questions

Risk management workshop according to ISO 14971

The workshop is designed for 1-2 days. Our suggestion for the first day is as follows:

  • Introduction to the act of medical devices:
    • What is a medical device - what is a system and what is a combination?
    • The philosophy of the directive: The security concept
    • Coherences between medical devices monitoring system and medical devices detection system, complaint handling and risk management
  • Harmonized standards according to risk management: ISO 14971 / ISO 1441 ?
  • Legal requisitions of the directive and of the act of medical devices about instruction manual and technical documentation
  • Product development modell
  • Introduction in the mode of operation and implementation of a risk analysis for a sample product:
    • Risk management plan
    • Risk management team
    • Grey-box-modell
    • Risk management process
    • Criteria for quantitative design
    • Risk graph
    • Evaluation including evaluation of the remaining risk
  • Open discussion

This workshop takes place in your company. According to your business operating area the workshop can be extended according to your wishes.

Screenshots Qware Riskmanager
Here you get an overview which companies already use Qware Riskmanager the market leading software for risk management according to DIN EN ISO 14971.
Advantages at a glance
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