TGFR Consulting LLC
Transforming Medical Device Development
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 …
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 …