Risik Management in the Usability Engineering Process

An essential part of the usability engineering process is risk management and its documentation. The standard ISO 14971 describes the procedure, which is also a requirement for the CE conformity marking and the approval of medical products and in-virtro-diagnostics by the FDA (Food and Drug Administration).

The Risk Management File, i.e. the summary of the conducted risk management, is the core of your Usability Engineering File. At the same time, the Risk Management File forms the basis of your entire technical documentation required for the CE conformity marking in Europe. The conducted risk management allows you to perfectly prove how you meet the fundamental requirements of the applicable guideline. However, the FDA also requires a Risk Management File which incorporates a "human factor".

Risk Management that accompanies the development reduces the time to market"

Risk Management is intended to accompany the development to considerably reduce the work and communication efforts, especially if several development partners are involved. For this purpose, Medical Safety Design is able to support you also in the scope of the usability engineering process providing a long experience, which especially pays off in development projects across departments or companies.

The method of risk management is not only suitable for product development but also for easier and more systematic process optimization and validation. Jörg Stockhardt consulting & more can also provide efficient and target-oriented support here. You define the model between Validation Master Plan and Global Harmonization Task Force and we support you as regards the implementation.

A new development is to apply risk management company-wide to prevent a company from risks that threat its continuance. Benefit from our process experience - The valuation remains your own decision.