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Use-Related Risk Management

An ISO 14971 compliant risk management process spans the entire product lifecycle. At Ergonomics Factory, we have significant experience performing use-related risk analysis, defining effective risk control measures and evaluating their effectiveness, and creating corresponding documentation. In addition, we provide full traceability between identified risks and their respective risk control measures, and support regulatory review.

Use-Related Risk Management
Known use problems analysis (KUPA)

Known use problems analysis (KUPA)

We identify known and foreseeable hazards and hazardous situations to provide the basis for the use-related risk analysis and the definition of risk control measures. We highly recommend performing the known use problems analysis as early as possible during the design and development process to support selecting the most suitable technology and the definition of use requirements.

We identify known and foreseeable hazards and hazardous situations to provide the basis for the use-related risk analysis and the definition of risk control measures. We highly recommend performing the known use problems analysis as early as possible during the design and development process to support selecting the most suitable technology and the definition of use requirements.

Analysis of known use problems with:

  • Previous models

  • Similarly marketed (predicate) devices

Hierarchical task analysis (HTA)

Hierarchical task analysis (HTA)

The HTA is the backbone of the use-related risk assessment and user interface specification. It identifies known and foreseeable hazards and hazardous situations in each intended use step and, thus, pinpoints user interface characteristics related to safety and potential use errors.

  • Definition of the task steps and task step sequences

  • Description of success criteria for each task step

  • Identification of use scenarios for each user group

Use-related failure modes and effects analysis (uFMEA)

Use-related failure modes and effects analysis (uFMEA)

The uFMEA systematically builds on the hierarchical task analysis (HTA) and KUPA. We identify known and foreseeable hazards and hazardous situations related to each use step, identify the user interface characteristics related to safety and potential use errors, and define risk control measures in alignment with your technical team.

  • Identification of hazards, hazardous situations, and potential harms

  • Definition of critical tasks, evaluation of risks, and risk control requirements

  • Documentation of implemented risk control measures

  • Evaluation of residual risks

Risk control definition, implementation, and evaluation

Risk control definition, implementation, and evaluation

Through our vast experience supporting risk management activities across many different product types and therapeutic areas, we can provide significant support with defining and implementing effective risk control measures. We can also rigorously evaluate the effectiveness of your existing risk control measures.

  • Definition of risk control measures based on previous risk analysis activities

  • Input to requirements and specifications

  • Implementation of risk control measures

  • Formative and/or summative evaluation of implemented risk control measure effectiveness

Risk management review support

Risk management review support

Use-related data is an essential part of every medical device risk management review. We support risk management reviews, integrating use-related risks into the overall risk management assessment, and creating the required documentation.

  • Identification of all relevant residual use-risks

  • Presentation of relevant use-related residual risks and risk controls

  • Integration of use-related risks into the overall risk evaluation

  • Supporting the documentation of the risk management review outcome and conclusions

Risk assessment update

Risk assessment update

We review available use-related data, ranging from human factors studies to clinical studies, as well as complaint management and other post-market surveillance activities.

  • Review of the available use-risk-related data

  • Identification of applicable use-risk-related data

  • Updating the use-related risk analysis and defining risk control measures

  • Evaluating and documenting the effectiveness of the risk control measures

  • Updating requirements and specifications