Risk Management and Risk Analysis



Why Risk Analysis?

The various European Directives for Medical Devices tell the manufacturers to assess the risk for the user and the patient, associated with the use of the device. Furthermore, a good risk analysis will accelerate the development process, will provide useful information with respect to the manufacturing process and quality control, and will be a valuable source of information for troubleshooting, customer services, etc.


How to carry out Risk Analysis?

The European Directive does not specify how risk analysis should be performed. However, harmonized standard ISO14971 has been developed to explain how it can be done. Meeting the requirements of this harmonized standard, automatically implies compliance with the Directive’s requirement on risk analysis.

ISO14971 refers to risk analysis methodologies, such as Fault Tree Analysis and Failure Mode Effects Analysis, which are established methods commonly used in the different branches of the industry.


Why Qarad’s Roadmap to Risk Analysis?


Experience has taught us that it is not easy to carry out risk analysis in a company:

  • Many questions arise and remain unanswered
  • Discussions on the approach to be followed
  • Misunderstanding of various terms
  • Lack of guidance: where and how to start the risk analysis?

This all leads to a lengthy process and unsatisfactory results.

Qarad’s Roadmap leads you stepwise through the process, providing structure and guidance along the way.

The end result is a risk analysis report, which is:

  • Transparent and well-structured
  • Consistent
  • Highly compliant with regulatory requirements


Characteristics of Qarad’s Roadmap to Risk Analysis


  • Highly compliant with regulatory requirements
  • Based on ISO14971
  • Using Failure Mode Effects Analysis (FMEA) as a risk assessment method
  • Modular structure, facilitating exchange of data between risk analysis of different products

Because of these characteristics, a risk analysis report and its supporting documentation are highly transparent and easily recognizable to auditors and other readers.


Features of the Risk Analysis package

Manual, containing brief explanation of the general principles of FMEA explanation of the principles of Qarad’s Roadmap.

Step-by-step guidance to carry out the risk analysis templates for:

  • Risk analysis summary - acceptance of residual risk
  • Risk analysis report
  • FMEA tables
  • Lists of hazards applicable to In Vitro Diagnostics

CD-ROM, containing electronic versions of templates for:

  • Risk analysis summary - acceptance of residual risk
  • Risk analysis report
  • FMEA tables
  • Examples


Additional support and training

Qarad can provide training on risk management and risk assessment, using the Qarad Roadmap, or provide assistance by e-mail or telephone. Ask for prices.


Proven concept

Qarad’s risk analyses of HIV, HCV, HLA, other assays and of medical devices have been assessed by a Notified Body and found to be meeting the regulatory requirements.



EN ISO 14971: Medical Devices - Application of risk management to medical devices.


Risk Analysis
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