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Integrated Discovery, Development  &

Regulatory Services

Medical Device Testing

Bioneeds is routinely evaluating Biological safety of different types of medical devices as per ISO 10993. The data generated by our studies have been submitted to the FDA, EU and other regulatory agencies. Our clientele includes national and international companies including UK, France, US, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Uganda, etc.

Cytotoxicity

  • Agar overlay
  • MEM elution
  • Direct contact
  • MTT assay
  • Colony formation

Sensitization

  • Maximization test
  • Closed patch (Buehler)
  • Local lymph node assay

Irritation

  • Intra cutaneous reactivity
  • Dermal irritation
  • Ocular irritation
  • Mucous membrane Irritation test

Hemocompatibility

  • ASTM hemolysis test - Direct and Indirect contact
  • Prothrombin time (PT)
  • Complement activation

QA / QC Testing

  • Bio-burden
  • Bacterial endotoxin (LAL)
  • Sterility testing

Regulatory Guidelines

  • ISO10993 and MHLW
  • USP
  • ASTM

Systemic Toxicity

  • Acute, Sub-acute, Subchronic and Chronic
  • Reproductive toxicity
  • Pyrogen test

Geno-toxicity

  • AMES test
  • Cell gene mutation assay
  • In vitro and In vivo micro nucleus
  • Chromosomal aberration test

Implantation Test

  • Intramuscular
  • Subcutaneous
  • Intraocular
  • Bone

 

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