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 delivers GLP-Compliant Large Animal Models for Comprehensive Medical Device Validation, providing scientifically rigorous preclinical data to de-risk regulatory pathways. As a trusted preclinical CRO, we specialize in orthopedic, cardiovascular, dental & active implant studies with species-specific physiologic relevance.

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Why Choose Huateng Bio for GLP-Compliant Testing?

Global Compliance: AAALAC-accredited facilities with IACUC protocols aligned with EU Directive 2010/63/EU and USDA standards.

Advanced Imaging: DSA, IVUS, angiography, and micro-CT for real-time device performance tracking.

Custom Model Development: Species-specific animal models for complex disease states.

Histopathology Suite: SEM/TEM analysis with GLP-grade reporting for PMDA/CE Mark submissions.

Send Us A Message

Custom Hotline

+86 15217198166


Email

huatengbiotechnology@gmail.com

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