Pathology Services Compliant with NMPA and FDA

Necropsy & Gross Observation
Histology & Staining
Histopathology Evaluation
Whole Slide Scanning & Histomorphometry
ICH
Rat
Mouse
Guinea Pig
Rabbit
Dog
Monkey
Pig
Sheep

Our Professional Pathology Services

Pathology Studies
Left image Implantation Studies: Bone, Muscle, Subcutaneous
Left image Toxicity Studies: Acute, Subchronic, Chronic
Left image Irritation Studies: Rectum, Vagina and Penis
Left image Surgical Studies: Orthopedic Model, Cartilage Defect model, Cardiovascular model, etc
Medical Device Products
Left image Bone and Cartilage: Bone Plate, Spinal Fixation System,Screws, Bone Cement, 3D Printed Implant, etc.
Left image Cardiovascular: Embolization Microspheres, Fluid Embolization System, Guidance Catheter, Balloon Catheter, Coronary Stent, Thrombosis Catcher, etc.
Left image Skin And Soft Tissue: Anastomotic Nails, Sutures, etc.
Left image Nervous System: Cortical Electrodes, etc.
Left image Others: Bronchial Ablation

Pathologists

Left image

Veterinary Pathologists accredited by the American College of Veterinary Pathology (DACVP)
Left image

ACVP Consultants Team providing expert veterinary pathology support
Left image

Veterinary Pathologists accredited by the Chinese College of Veterinary Pathology (DCCVP)
Left image

Toxicologists accredited by the Chinese Society of Toxicology (DCST)

Necropsy & Gross Observation

Euthanasia Procedures: Small and large animals (Rat, Mouse, Dog, Monkey, Rabbit, Guinea Pig, Mini Pig, Sheep)

Blood Collection at Termination

Full Panel Tissue Collection

Special Tissue Collection: Frozen Tissue, RNA, IHC

Tissue Fixation: 10% Formalin, Modified Davidson’s, Perfusion Fixation, Other Fixatives

Data Collection: Organ Weight Data, Gross Observation Data

Euthanasia Procedures: Small and large animals (Rat, Mouse, Dog, Monkey, Rabbit, Guinea Pig, Mini Pig, Sheep)

Blood Collection at Termination

Full Panel Tissue Collection

Special Tissue Collection: Frozen Tissue, RNA, IHC

Tissue Fixation: 10% Formalin, Modified Davidson’s, Perfusion Fixation, Other Fixatives

Data Collection: Organ Weight Data, Gross Observation Data

Histology Services & Workflow

Hard Tissue Processing Workflow

Histology Embedding Methods

Embedding by Resin-For Hard Tissue Section

Embedding by Paraffin-For Paraffin Section

Paraffin Section – H&E Staining

Lung

Kidney

Cerebellum

Hard Tissue Sections

HE Staining

Bone - Metal Implant

Coronary Stent

Special Staining

Bone - Von Kossa

Bone - Goldner’s Trichome

Histopathology Evaluation

Key Observation Points in Histopathology

Interface between device and tissues (Local effect around implant, inflammation, fibrosis, necrosis, infection, etc.)

Adjacent Tissue Damage (Degeneration/Necrosis, vasculitis, etc.)

Other Findings (Infarction, congestion, thrombi, etc.)

Select the Applicable Scoring System

Routine Tissue Evaluation Term: INHAND

Local Effect around Implant: ISO 10993-6&GB/T16886.6

Special Scoring System: e.g. Scoring system to blood vessels, Cartilage Defect -Modified O’Driscoll Scoring System

Photography for Representative Findings

Histomorphometry

Equipment

Olympus CellSense

NIKON NIS-Elements D

BIOQUANT OSTEO Scanning Microscope and Image Analysis System (Whole Slide Scanning and Analysis for both Paraffin and Hard sections)

Measurement Parameters

Length

Area

New Bone Formation

Bone-Implant Contact, BIC

Materials Degradation

Cell Numbering

……

To learn more about medical device testing, please contact us.