Press Release

MedTech Intelligence exclusive: How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions

July 20, 2015

FDA Expectations for Human Factors

The July 20, 2015, edition of MedTech Intelligence features How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions, an exclusive article written by StarFish Medical Industrial Designer, James Jackson.

The article reviews each of six distinct phases in the  evolved process: Preliminary analysis, Usability inspection, Usability testing, Trial usability validation, and Usability validation.  Jackson advises, “Relying on tangible data, and basing development decisions on assured design inputs, will help ensure your products’ success through the regulatory process and in the market.”

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