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Integrated Discovery, Development  &

Regulatory Services

Testing Services for Medical Devices

Bioneeds provides state-of-the-art testing services for medical devices under GLP. The subject matter experts in every field for medical devices will suggest the studies required for device. With expertise in ISO and FDA medical device regulations, We support for your orthopedic, dental, ophthalmic, cardiovascular, respiratory, PPEs, and other preclinical medical device testing programs.

We routinely evaluate biocompatibility as per ISO 10993 and we are OECD GLP certified and ISO 17025 accredited Laboratory. The data generated at Bioneeds has been well accepted by USFDA (for 510K & PMA), EU (for CE Marking), and other regulatory agencies. Bioneeds clientele includes National and International companies from India, UK, France, US, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan & ROW

Following tests are routinely conducted in our laboratory.

Cytotoxicity Test

  • Agar overlay assays
  • Elution method
  • MEM elution
  • MTT assay / XTT assay
  • Neutral Red Uptake (NRU)
  • Colony formation

Irritation Test

  • Primary skin irritation
  • Intracutaneous reactivity
  • Ocular irritation
  • Mucosal irritation (oral, rectal, vaginal & penile)

Sensitization Tests

  • Buehler sensitization method
  • Maximization (magnus-kligman)
  • Local Lymph Node Assay (LLNA)

Systemic Toxicity Tests

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

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

Pyrogenicity Tests

  • in vitro bacterial endotoxins
  • Material mediated rabbit pyrogen test

Implant Tests

  • Intramuscular
  • Subcutaneous
  • Bone
  • Relevant clinical site (Ex: intraperitoneal, bone / joint, dental, spine, ocular & calvarial)

Plastics Testing

Biocompatibility tests for classifications of plastics (USP class VI test)

Medical Device Toxicity Risk Assessment

Genotoxicity Test

  • Bacterial mutation (AMES) test
  • Mouse lymphoma assay
  • in vitro & in vivo micronucleus
  • in vitro & in vivo chromosomal aberration

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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