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Integrated Discovery, Development  &

Regulatory Services

Medical Device Testing

Bioneeds routinely evaluates Biological safety for varied types of Medical Devices as per ISO 10993. Data generated at Bioneeds has been well accepted by USFDA (for 510K & PMA), EU (for CE Marking) and other regulatory agencies. Our clientele includes national and international companies viz. UK, France, US, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan & ROW.

Cytotoxicity Tests

  • Agar Overlay
  • MEM Elution
  • MTT Assay / XTT Assay
  • Neutral Red Uptake
  • Colony Formation

Systemic Toxicity Tests

  • Acute
  • Sub-acute
  • Sub-chronic
  • Chronic

Implant Tests

  • Intramuscular
  • Subcutaneous
  • Bone
  • Relevant Clinical Site (Ex: Intraperitoneal, Bone / Joint, Dental, Spine, Ocular and Calvarial)

Genotoxicity Tests

  • Bacterial Mutation (AMES) Test
  • Mouse Iymphoma
  • In vitro & In vivo micronucleus
  • In vitro & In vivo chromosomal aberration

Irritation Tests

  • Primary Skin Irritation
  • Intracutaneous Reactivity
  • Ocular Irritation
  • Mucosal Irritation (Oral, Rectal, Vaginal & Penile)

Hemocompatibility Tests

  • Hemolysis Test
  • Prothrombin Time (PT)
  • Partial Thromboplastin Time (PTT / Inactive PTT)
  • Complement Activation (C3a & SC5b-9)
  • Platelet Aggregation / Activation
  • Coagulation
  • Thrombosis / Fibrinolysis
  • Leukocyte Activation

Plastics Testing

Biocompatibility Tests for Classifications of Plastics (USP Class VI Test)

Medical Device Toxicity Risk Assessment

 

Sensitization Tests

  • Buehler Sensitization Method
  • Maximization (Magnus-Kligman)
  • Local lymph Node Assay (LLNA)

Pyrogenicity Tests

  • In vitro Bacterial Endotoxins
  • Material Mediated Rabbit Pyrogen Test

Others

  • Carcinogenicity
  • Reproductive Toxicity
  • Teratogenicity
  • Immunotoxicity / Immunogenicity

Regulatory Guidelines

  • ISO 10993
  • ASTM
  • US FDA
  • AAMI
  • Product Specific ISO Guidelines
  • Pharmacopoeia (USP / BP / IP)

 

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