IVDR Services

IVDR Performance Study Documentation
•Performance Study Documentation Development
•Performance Study Templates
•Device Safety Recording and Reporting
•Device Monitoring Plan
•Project Management

Diagnostic Device Documentation Services
•CFR 820 and IVDR Compliant
•AV Documentation Review and Generation
•Study Design


Clinical Performance Study Execution
•CRO Management
•Diagnostic Partner Management and Support
•Clinical Trial Monitoring
•EC Management
•Device Monitoring
•Site Selection, Evaluation and Management
Reporting and Record Keeping
•Management of (e)TMF and EDC
•Close Out Reports
•Clinical Performance Study Report
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