Medical Device Testing in vivo

Preclinical CRO Services

Medical Device Testing in vivo

Preclinical Excellence for Safer, Smarter Medical Innovations

At HuaTeng Biotechnology, we specialize in GLP-compliant in vivo testing for medical devices, delivering robust preclinical data to accelerate regulatory approvals (FDA, CE, NMPA) and ensure patient safety. Our advanced animal models, state-of-the-art facilities, and ISO 10993-aligned protocols empower innovators to validate device performance, biocompatibility, and long-term efficacy with confidence.

Core Services

Functional Performance Testing

Cardiovascular Devices

Stent patency, heart valve durability (porcine models).

Orthopedic Implants

Bone integration, wear resistance (rabbit, sheep).

Neurological Devices

Electrode biocompatibility (rodent, NHP).

Drug-Device Combinations

Coated stents, insulin pumps (diabetic minipigs).

Biocompatibility & Safety Testing

Acute/Chronic Toxicity

Sensitization & Irritation Testing

Hemocompatibility (Blood Contact Devices)

Implantation Studies (7d to 12+ months)

Genotoxicity & Carcinogenicity Screening

Surgical Simulation & Training

Custom Surgical Models

Replicate human anatomy for device deployment practice.

Surgeon Training Programs

Hands-on workshops using our animal facilities.

GLP Large Animal Studies

HuaTeng Biotechnology provides GLP-compliant large animal models to support comprehensive medical device validation. Our studies generate scientifically rigorous preclinical data, helping to de-risk regulatory pathways and accelerate global approvals. We bring deep expertise across orthopaedic, cardiovascular, dental, and active implant studies, with strong emphasis on species-specific physiological relevance and translational study design.

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Why Choose HuaTeng Biotechnology for GLP-Compliant Testing?

Trusted Quality. Global Compliance. Proven Execution.

Global Compliance: AAALAC-accredited facilities with IACUC oversight, aligned with EU Directive 2010/63/EU and USDA standards—ensuring full regulatory acceptance across major markets.

Advanced Imaging Capabilities: Integrated platforms including DSA, IVUS, angiography and micro-CT, enabling real-time evaluation of device performance and in vivo outcomes.

Custom Model Development: Species-specific animal models tailored to complex disease conditions, improving translational relevance and clinical predictability.

Integrated Histopathology Suite: SEM and TEM analysis supported by GLP-grade reporting, enabling seamless submission to PMDA, CE Mark and global regulatory authorities.

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+86 15217198166

Email

ht@htscience.com

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