Medical Device Testing Services

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.

We 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 & ROW

Mutagenicity Lab

Following tests are routinely conducted in our laboratory.

Cytotoxicity Test

Qualitative tests

  • MEM Elution
  • Agar Overlay Assays
  • Direct Contact Test

Quantitative tests

  • MTT Assay
  • XTT Assay
  • Neutral Red Uptake (NRU)
  • Colony Formation

Irritation Test

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

Skin Sensitization Tests

  • Buehler Sensitization Method
  • Guinea Pig Maximisation Test (Magnusson-Kligman)
  • Local Lymph Node Assay (LLNA)

Systemic Toxicity Tests

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

Hemocompatibility Tests

  • Hemolysis Test
  • Partial Thromboplastin Time (PTT)
  • Complement Activation (C3a & SC5b-9)
  • Platelet Aggregation / Activation
  • Leukocyte Activation Test
  • Haematology Test

Pyrogenicity Tests

  • In vitro Bacterial Endotoxins
  • Material Mediated Rabbit Pyrogenicity Test

Implantation Studies

  • Intramuscular
  • Subcutaneous
  • Bone

Plastics Testing

  • In vitro Biological Reactivity Tests
  • In vivo Biological Reactivity Tests

Others

  • Carcinogenicity
  • Reproductive Toxicity
  • Teratogenicity

Genotoxicity Testing

  • Bacterial Reverse Mutation (AMES) Test
  • Mouse Lymphoma Assay
  • In vitro & In vivo Micronucleus Test
  • In vitro & In vivo Chromosomal Aberration

Biological Safety Evaluation

  • Biological Evaluation Plan
  • Toxicological Risk Assessment
  • Biological Evaluation Report

Regulatory Guidelines

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