Medical Device Safety Assessment
Medical Device Safety Assessment Services
Pharmaron has established a medical device safety assessment service platform to address the preclinical medical device safety evaluation needs in support of 510k and PMA submissions to regulatory agencies.
Our team is experienced in designing and executing studies based on attributes of a medical device, with an adequate selection of animals and clearly defined safety parameters, supported by clinical pathology and histopathology, etc., to evaluate potential risks of illness and injury associated with the use of the device for its intended uses and conditions of use. The medical device safety assessment studies are conducted in GLP-compliant facilities.
Animal Species include rodents, rabbits, dogs, pigs and mini-pigs (Yorkshire, Gottingen, Yucatan) and sheep.
Disease Models: Aneurysm, myocardial infarction, thrombo-occlusive, partial or full-thickness wounds/burns, diabetic models
Capabilities
Medical Devices Tested in Our Facilities
- Drug-eluting devices
- Grafts and scaffolds
- Catheters
- Vascular implants
- Stents (mitral & aortic valves); Guide wires (vascular access)
- Clot retrievers
- Continuous Glucose Sensory Monitors
- Endoscopic evaluation
- Ocular: contacts, novel orbital implants, pumps & drug-delivery, dermal
Diagnostics and Imaging Modality Devices
- Fluoroscopic radiography (C-Arm OEM 9900)
- Ultrasound
- ICE: Intra-cardiac Echocardiography
- TTE: Transthoracic Echocardiogram
Support for Analytical and Imaging Platforms
- Blood Gas Measurement (iSTAT)
- Clinical pathology (clinical chem., hematology, coagulation)
- Histopathology
- Biomarker analysis
- Fluoroscopy
- Ultrasound: Intra-Cardiac Echocardiography, Trans-esophageal Echocardiography, Trans-Thoracic Echocardiography
- Endoscope
- Laparoscopic Unit
Download our PDF to learn more about our safety assessment services.
