Trusted Medical Device Testing Services for Global Compliance

Adita Biosys provides state-of-the-art medical device testing services under GLP and ISO 17025 standards, ensuring compliance with global regulatory requirements. Our subject matter experts in biological evaluation assist in selecting the necessary studies for your device, helping meet international safety and efficacy standards.

We provide ISO 10993, ASTM, US FDA, and MHLW-compliant biocompatibility testing for medical devices as an OECD GLP-certified & ISO 17025-accredited lab. Ensuring USFDA (510K & PMA), EU (CE Marking), and global compliance, we are trusted by clients worldwide.

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Biological Safety Evaluation for Medical Devices

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)