Medical Devices
Medical Devices CRO in India
Vipragen Bioscience provides following types of medical device services according to the ISO 10993 guidelines and other applicable international guidelines as per client’s requirements.
Biocompatibility Testing
- » Cytotoxicity Testing (ISO 10993-5)
- » Agar Overlay
- » MEM Elution MTT Assay / XTT Assay
- » Neutral Red Uptake
- » Colony Formation
- » Systemic Toxicity Tests (ISO 10993-11)
- » Acute Toxicity
- » Sub-acute Toxicity
- » Sub-chronic Toxicity
- » Chronic Toxicity
- » Implantation Tests (ISO 10993-6)
- » Intramuscular
- » Bone
Genotoxicity Tests (ISO 10993-3 & ISO/TR 10993-33)
- » Bacterial Mutation (AMES) Test
- » In-vitro & In-vivo micronucleus
- » In Vitro and In Vivo Chromosomal Aberration Test
- » Irritation Tests (ISO 10993-23)
- » Primary Skin Irritation
- » Intracutaneous Reactivity
- » Ocular Irritation
- » Mucosal Irritation (Oral, Rectal, Vaginal & Penile)
- » EpiSkin Dermal and Eye Irritation
Hemocompatibility Tests (ISO 10993-4 & ASTM)
- » Hemolysis Test Prothrombin Time (PT)
- » Partial Thromboplastin Time (PTT / Inactive PTT)
- » Complement Activation (C3a & SC5b-9)
- » Platelet Aggregation / Activation
- » Coagulation
- » Thrombosis / Fibrinolysis
- » Platelet and Leukocyte Activation
USP Class VI Plastic Testing
- » Sensitization Tests (ISO 10993-10)
- » Buehler Test
- » Guinea-pig Maximization Method
Pyrogenicity Tests (ISO 10993-11, USP and EP)
- » Bacterial Endotoxin Testing
- » Material Mediated Pyrogenicity testing
Immunogenicity Studies (ISO 10993-20) Regulatory Submission
- » Gap Analysis
- » Toxicity Assessment (ISO 10993-17)
- » Device Master File Preparation
Batch Release Testing
- » Sterility Testing
- » Bio-burden Testing
- » Growth Promotion Test
- » Packaging Inspection
- » Shelf Life