Risk Management and Assessment

Qarad's roadmap to Risk Management

Why?

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.

Characteristics

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.

Practical

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

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QARAD B.V.B.A.

ISO 13485 Certified

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