Preclinical Testing

The preclinical testing of a medical device is performed to determine the performance and safety based on the benchmark values.

Based on the complete knowledge of regulation, guidelines and standards, STEMart provides a comprehensive portfolio of safety and efficacy services including imaging modalities and diverse histological endpoints. Our experts including dedicated veterinary pathologists conduct a complete histopathological analysis and produce resulting quantitative reports for manufacturers.

Preclinical Testing Services

• Develop GLP and non-GLP protocol
• Evaluate prototype
• Multi-species in vivo testing
• Evaluate and develop appropriate animal models or select appropriate human anatomic models for a wide range of medical device types, including:
• Cardiovascular
• Tissue engineering
• Wound healing
• Drug deliver
• Dental
• Gastrointestinal
• Neurologic
• Ophthalmology
• Orthopedic
• Urogenital
• Dermatology
• Complex surgical procedures

Our experienced surgeons provide valuable feedback on product performance and optimize treatment procedures steps in preparation for human clinical cases.

• Histopathology and analytical testing
• Gross pathology by a board-certified veterinary pathologist
• Paraffin embedding and sectioning
• Resin/Plastics embedding with Cut & Grind or sectioning for metallic devices and bone
• Immunohistochemistry
• Drug content testing on devices, blood, tissues and urine
• Biomarker analysis

And more

• Imaging equipment for documenting the placement and performance of implanted device:
• Fluoroscopy
• General ultrasound
• ICE (intracardiac echocardiography)
• IVUS (intravascular ultrasound)
• Laparoscopic towers
• TEE (transesophageal ultrasound)
• Transthoracic ultrasound
• Regulatory support
• Voice of the customer evaluation

SETMart provides a one-stop, client-specific preclinical medical devices testing throughout the innovation and product development cycle. If you want to learn more detail about our physical testing service, or would like to consult with the experts at STEMart, please feel free to contact us.