F L T G Y

Integrated Discovery, Development  &

Regulatory Services

Testing Services for Medical Devices

Bioneeds provides state-of-the-art testing services for medical devices under GLP and ISO 10725 standards. The subject matter experts in every field for medical devices will suggest the studies required for the 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.

Bioneeds provides state-of-the-art testWe routinely evaluate biocompatibility as per ISO 10993. 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 & ROWing services for medical devices under GLP and ISO 10725 standards. The subject matter experts in every field for medical devices will suggest the studies required for the 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.

Following tests are routinely conducted in our laboratory.

Cytotoxicity Test

Qualitative tests

  • MEM Elution
  • Agar Overlay Assays
  • Direct Contact Test

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)

All © Rights Reserved To Bioneeds India Private Limited - 2020

F L T G Y