Equip your product for success
Helping your device or diagnostic realize its full potential requires navigating complex regulatory and development environments.
Extensive experience for comprehensive insights
Our medical devices and diagnostics services span the globe (including United States, Europe, Latin America and Asia Pacific) and include:
- Preclinical and regulatory consulting
- Clinical trial services
- Post-market interventional studies
- Post-market observational studies
- Our expert team includes industry veterans and ex-agency personnel who draw from their experience in the US Food and Drug Administration (FDA), the FDA's Center for Devices and Radiological Health (CDRH) and almost every device review organization within the FDA.
We also bring you the dedicated expertise of Novella Clinical
, a Quintiles Company, which offers more than a decade of experience and a broad range of therapeutic concentrations in devices and diagnostics, including cardiovascular, orthopedic/spine, general surgery and oncology.
With Quintiles, you have the regulatory expertise and global footprint to support your medical device success.