Risk Management and Assessment

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 be meeting the regulatory requirements!

Contact us for more information



ISO Certified
ISO 13485 and ISO 27001


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