Across the diagnostic device spectrum, PPD's medical device team provides strategic and clinical trial support for new diagnostic devices and indications. Our experience includes simple normal and healthy sample collection and rigorous investigational device exemption (IDE) trials required by the U.S. Food and Drug Administration (FDA).
PPD offers substantial experience in device and diagnostic study execution, strong leadership and significant regulatory experience with Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety and the Center for Devices and Radiological Health (CDRH).
Diagnostic Clinical Trial Experience
We have diagnostic experience in:
- Hepatitis B
- Cardiology (HF)
- West Nile
- A & B viruses
- Simple normal and healthy
- Wound (AI)