Risk Management and Risk Assessment



Why Risk Management?

The various European Directives and Regulations for In Vitro Diagnostics and 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 management 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 Management?

The European Directive nor the Regulation does not specify how risk management 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 and Regulations' requirements on risk management.

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


Why Qarad’s Roadmap to Risk Management?


Experience has taught us that it is not easy to carry out risk assessment 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 assessment?

This all leads to a lengthy process and unsatisfactory results.

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

The end result is a risk management 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 management method
  • Modular structure, facilitating exchange of data between risk management of different products

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


Features of the Risk Management 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 management templates for:

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

Digital templates for:

  • Risk Assessment summary - acceptance of residual risk
  • Risk Management 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
« Our team was very positive about your audit and approach. »

Tecan benelux Bvba


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