Medical Devices
Services to evaluating safety and effectiveness for medical devices
Optimize time and budget with characterized in vivo models and tap into Pharmaron’s expertise to meet unique study requirements to evaluate safety and effectiveness for medical devices. Our team has the resources and expertise to perform a wide range of in vivo preclinical tests of medical devices with the ultimate goal of helping our clients attain successful 510(k) or PMA submissions.
Our Services
Therapy Device
- Drug-eluting devices
- Grafts and scaffolds
- Catheter devices
- Vascular implant devices
- Stents – mitral valves, aortic valves
- Guide wires – vascular access
- Clot retrievers
- Continuous Glucose Sensory Monitors (CGM)
- Endoscopic evaluation
- Biochips
Our Services
Diagnostics/Imaging Modalities
- Fluoroscopic radiography (C-Arm OEM 9900)
- Ultrasound
- ICE: Intra-cardiac Echocardiography
- TTE: Transthoracic Echocardiogram
- CFD (Computational Fluid Dynamics)
- Blood Gas Measurement (iSTAT)
Our Services
Supporting Analytical Readouts
- Clinical pathology (clinical chemistry, hematology, and coagulation)
- Histopathology
On-demand Webinar
Learn more about why in vivo testing is needed for regulatory approval of a Medical Device and what specific testing is required.