Medical Device Testing Services

Leveraging profound expertise in international (ISO) and United States Food and Drug Administration (FDA) medical device regulations, eToxLab offers comprehensive preclinical testing support for diverse therapeutic sectors, including orthopedics, dentistry, ophthalmology, cardiovascular, respiratory, and personal protective equipment (PPEs).

Our core competency lies in rigorous biocompatibility assessments adhering to the stringent ISO 10993 standards. As an OECD Good Laboratory Practice (GLP) certified and ISO 17025 accredited laboratory, eToxLab generates high-quality data consistently accepted by regulatory bodies worldwide, including the USFDA (510(k) and PMA submissions), the European Union (CE Marking), and others.

Our esteemed clientele encompasses national and international companies spanning India, the United Kingdom, France, the United States, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan, and beyond.

Routine Laboratory Procedures for Medical Device Evaluation

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

Other Tests

           Carcinogenicity
           Reproductive Toxicity
           Teratogenicity
Genotoxicity Testing

           Bacterial Reverse Mutation (AMES) Test
           Mouse Lymphoma Assay
           In-vitro and In-vivo Micronucleus Test
           In-vitro and 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)

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