The How to get a CLIA Waiver for your Medical Device 2015 covers topics such as:
- FDAs 2008 CLIA Waiver Guidance and cope with its shortfalls
- FDAs CLIA categorization scoring criteria
- Flex studies based on risk analysis
- Integrating human factors and usability engineering into CLIA Waived products
- Studies and sample panels to evaluate performance near the cutoff
- CLIA Waiver clinical studies for qualitative and quantitative devices
- CLIA Waiver application
- Compliant labeling for CLIA Waived products
- Statistical analysis of data
The How to get a CLIA Waiver for your Medical Device 2015 brings together:
- R&D Personnel
- Executives and Senior Managers
- Regulatory Professionals
- Design Engineers
- Risk Management Professionals
- Project Managers
- Clinical Research Professionals
