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.

Medical Devices

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