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Integrated Discovery, Development  &

Regulatory Services

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 and ROW.

  • Agar Overlay
  • MEM Elution
  • MTT Assay / XTT Assay
  • Neutral Red Uptake
  • Colony Formation
  • Acute
  • Sub-acute
  • Sub-chronic
  • Chronic
  • Intramuscular
  • Subcutaneous
  • Bone
  • Relevant Clinical Site (Ex: Intraperitoneal, Bone / Joint, Dental, Spine, Ocular & Calvarial)
  • Bacterial Mutation (AMES) Test
  • Mouse Iymphoma
  • In vitro & In vivo micronucleus
  • In vitro & In vivo chromosomal aberration
  • Primary Skin Irritation
  • Intracutaneous Reactivity
  • Ocular Irritation
  • Mucosal Irritation (Oral, Rectal, Vaginal & Penile)
  • Hemolysis Test
  • Prothrombin Time (PT)
  • Partial Thromboplastin Time (PTT / Inactive PTT)
  • Complement Activation (C3a & SC5b-9)
  • Platelet Aggregation / Activation
  • Coagulation
  • Thrombosis / Fibrinolysis
  • Leukocyte Activation

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

  • Buehler Sensitization Method
  • Maximization (Magnus-Kligman)
  • Local lymph Node Assay (LLNA)
  • In vitro Bacterial Endotoxins
  • Material Mediated Rabbit Pyrogen Test
  • Carcinogenicity
  • Reproductive Toxicity
  • Teratogenicity
  • Immunotoxicity / Immunogenicity
  • ISO 10993
  • ASTM
  • US FDA
  • AAMI
  • Product Specific ISO Guidelines
  • Pharmacopoeia (USP / BP / IP)

Medical Devices

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