TGFR Consulting LLC
Transforming Medical Device Development
Establishing the risks for the product and the risk management file elements. Ensuring that the product is safe and effective
After task analysis has identified the failure modes, the next step is the mapping of hazards to these failure modes, identifying the sequence of events, and identifying the hazardous situation(s). The following figure illustrates the overall flow.
Medical Device Task Analysis will form the basis of future risk and workflow development
Task and preliminary hazard analysis identify the risk controls that a concept must implement to provide adequate product safety. Inputs Key Activities Outputs Clinical UseThe clinical use of the device Clinical Use Error DataData on the use errors and rates associated with the data. Clinical Hazards and HarmsThe clinical hazards and harms associated with the therapy. …
The operational risk analysis forms the basis for the use case development. During the operational and functional analysis portion of the risk analysis, use cases have been identified and linked to the failure modes. This analysis needs to be formalized into use cases that can be translated into requirements. In most definitions of a use …
Based upon the evaluation of risk, mitigation of the hazardous situations will be needed. In determining the need for risk controls, care must be taken to align with the requirements of ISO 14971:2012. The approach to risk control should be based upon the risk for a hazardous situation and can be summarized as follows This …
Identification of all the hazardous situations associated with the therapy or procedure requires the identification of all actions (both user and device) associated with the execution of the therapy or procedure. Use of functional analysis, rather than starting with the failure modes of the device and assessing risk of the linked therapy or procedure actions, …
The therapy centric risk analysis begins with the identification of the hazards and the associated harms for the therapy or procedure. Hazards, a potential source of harm, should be specific to the therapy or procedure. Mapping to the therapy or procedure makes it easier to identify the possible harms associated with the hazard. For example, …
Risk analysis based upon the clinical use of the device must be performed prior to concept elaboration (the development of design inputs). Risk Analysis establishes essential requirements, the requirements associated with safety. These essential requirements will be blended with the concept realization to form the basis of the final design inputs. The following table …