FDA
The new article describes specific aspects related to human factors to be considered when assessing the safety and effectiveness of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article addresses specific aspects related to human factors validation testing, including the ones related to the analysis of test results, the approach to be applied concerning residual risk, and also validation testing of modified devices. ...
FDA
The new article addresses the matters related to data collection and describes in detail different types of information and the ways it could be collected. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
