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

Pathology Service Studies & Product Types

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
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

5

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

3

US St. Paul Senior Medical Device Pathologists(DACVP)
Left image

11

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

11

Study Pathologists

Necropsy & Gross Observation

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

Blood collection at Termination

Full Panel of Tissue Collection

Special Tissue : Frozen Tissue, RNA, IHC

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

Data Collection: Organ Weight Data, Gross Data

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

Blood collection at Termination

Full Panel of Tissue Collection

Special Tissue : Frozen Tissue, RNA, IHC

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

Data Collection: Organ Weight Data, Gross Data

Histology

Hard Tissue

Histology

Embedding by Resin-For Hard Tissue Section

Embedding by Paraffin-For Paraffin Section

Paraffin Section - HE Staining

Lung

Kidney

Cerebellum

Hard Tissue Section

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.