IVD Clinical Performance
Bioexcel supports studies where the intended user is not a healthcare professional.
Bioexcel supports studies where the intended user is not a healthcare professional.
Potential Assessments
- IFU comprehension
- Test setup
- Sample collection
- Device operation
- Timing
- Result reading
- Result interpretation
- Invalid-result handling
- User error
- Questionnaire
- User preference where relevant
Does Bioexcel Conduct Layperson IVD Studies?
Yes. Bioexcel can support layperson, self-testing and home-use IVD studies, including participant recruitment, device-use assessment, IFU comprehension, result interpretation, user questionnaires, data management and final reporting.
