FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices 2014 is a webinar that covers topics such as:
- General Principles
- The Guidance
- Clinical Outcome Studies
- Some Principles for the Choice of Clinical Study Design
- Sustaining the Quality of Clinical Studies
- Diagnostic Clinical Performance Studies
FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices 2014 brings together:
- Regulatory Affairs
- Clinical Trial Physician / Doctor
- Clinical Research
- Quality Assurance
- Data Monitoring
- Data Management
- Institutional Review Board
