Exclusive to Med-ERRS, our Focused FMEA looks at a unique aspect of a product, such as a dosage form, special packaging, or trademark. We employ Failure Mode and Effects Analysis (FMEA) to determine which path or choice to follow to minimize the risk of error and provide specific recommendations and error-reduction strategies.

We have also performed the Focused FMEA in response to specific FDA requests or to fulfill a Risk Evaluation and Mitigation Strategy (REMS).

The Focused FMEA might be used by pharmaceutical companies wishing to choose between the use of a dual trademark or the original trademark with a modifier (suffix) for a new product in their existing product line.