Risk management and risk assessment

Rely on the expertise of Qarad

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, 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?

Neither the European Directive nor the Regulation specifies how risk management should be performed. However, harmonized standard ISO 14971 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.

ISO 14971 refers to risk management methodologies, such as Failure Mode Effects Analysis (FMEA), which are established methods commonly used in the different branches of the industry.

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 arise 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 provides structure and guidance throughout the entire process.


The characteristics of Qarad’s Roadmap to Risk Assessment are:

  • Compliance with regulatory requirements
  • Based on ISO 14971
  • Using the 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.



Qarad’s Roadmap will gradually lead you through the process. You will receive a manual and 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

The end result is a complete Risk Management Report, which is transparent and well-structured.
Our proven concept has been assessed by a Notified Body and was found to meet regulatory requirements.

Contact us for more information