GLP Large Animal Studies

Preclinical Large Animal Studies for Medical Devices | GLP-Compliant

Our AAALAC-accredited facilities execute studies aligned with ISO 10993 (biocompatibility) and FDA/EMA/NMPA regulatory protocols. We bridge translational gaps through:
Anatomically predictive models (ovine/caprine orthopedics, porcine cardiovascular systems)
Surgical excellence under full IACUC oversight
Human-correlated endpoints (histomorphometry, µCT, biomechanical testing)

Core Service Areas

Orthopedic Implant Testing

Models

Ovine, caprine, porcine, canine

Assessments

Osseointegration & bone-implant interface analysis (µCT/histomorphometry)
Wear debris & biocompatibility (ISO 10993-6, -10)
Dynamic loading simulations (ASTM F2996)
Spinal devices, joint replacements, trauma fixation

Cardiovascular Device Evaluation

Models

Porcine, ovine

Applications

Endovascular stents, TAVR, occlusion devices
Thrombogenicity (ISO 10993-4), hemodynamic impact
Chronic implantation up to 180 days
Angiographic, IVUS, OCT endpoint analyses

Dental Implant & Maxillofacial Studies

Models

Minipig, canine, non-human primate

Protocols

Soft/hard tissue integration (ISO 22911)
Alveolar bone healing kinetics
Guided bone regeneration (GBR) material efficacy

Active Implantable Devices

Scope

Pacemakers, neurostimulators, drug delivery systems

Testing

Electromagnetic compatibility (IEC 60601)
Battery longevity & in vivo performance
Histopathological response to electronics

Compliance & Quality

Accreditations: AAALAC International, GLP (OECD)

Regulatory Alignment: Audit-ready reports for FDA 510(k), PMA, CE Mark, NMPA submissions

Biocompatibility Integration: Endotoxins, cytotoxicity, sensitization (ISO 10993 series)

Technical Capabilities

Area Technologies
Imaging µCT, angiography, MRI, radiography
Histology Undecalcified sectioning, SEM, IHC
Biomechanics Instron testing, finite element analysis
Data Analytics GLP-validated ELN, statistical power analysis

Send Us A Message

Custom Hotline

+86 15217198166

Email

huatengbiotechnology@gmail.com

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