Clinical Trials and Training for Medical DevicesSchedule for device approval

 
Biological Safety Biologycal Safety
Market Assessment Market Assessment
Regulatory strategy Regulatory Strategy
Protocol Protocol
Sample size Sample Size
Case report form design Case Report Form Design
Investigator Agreement INvestigators Agreement    
Budget & payment terms Budget and payment terms
Clinical Trials Agreement Clinical Trials Agreement
IRB Review & approval IRB Review and approvalmilestone1  
Initiation, first subject in milestone2
Monitoring close-out las subject out  
Close-out, last subject out milestone3
Database Design Database Design
Data entry, queries Statistical analysismilestone4  
Statistical analysis Regulatory submission, approval  
Regulatory Submission, approval Medical device to market  
TO MARKET

milestone5

Project Management
Training
CDG: Consulting and contracting...CRO-ing...biological safety...clinical research...
regulatory...medical device industry...in vitro diagnostics...since 1990.

CROing and Training for medical devices.
Get service strategies at 773-489-5706 or cdginc@clinicaldevice.com,
Get training details under eConferences