ISO 10993 Biocompatibility & Toxicology Testing Services for Medical Device

IngenesTM provides ISO 10993 Biocompatibility and Toxicology testing services for medical devices in partnership withGLP Certified and ISO 10725 standard accreditedlaboratory with state-of-the-artfacility and best-in-class infrastructure equipped with animal rooms that are built as per international standards. Our FDA Consultant, who is a subject matter expert that specialises inmedical devices will recommend the studies required for the device.

Our medical device testing services are provided as per the requirements of ISO and FDA medical device regulations. Our ISO 10725 standard compliant GLP Certified laboratory has the capability to perform preclinical evaluation of medical devices and biocompatibility testing for surgical, urology, plastic surgery, orthopaedic, dental, ophthalmic, cardiovascular, respiratory, PPEs andwound care products.

IngenesTM routinely performs biocompatibility & toxicology studies on medical devices in OECD GLP certified and ISO 17025 accredited Laboratoryas per ISO 10993. The data generated at IngenesTM has been well accepted by USFDA for 510(k) & PMA submissions, EU (for CE Marking) and other regulatory agencies. IngenesTM clientele includes National and International medical device companies from US,UK, Canada, India, and China.

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
  • Intracutaneous Reactivity
  • Ocular Irritation
  • Mucosal/Special Irritation Test (Oral, Rectal, Vaginal & Penile)
Pyrogenicity Tests
  • In vitro Bacterial Endotoxins
  • Material Mediated Rabbit Pyrogen Test
Implant Tests
  • Intramuscular
  • Subcutaneous
  • Bone
Plastics Testing
  • In vitro Biological Reactivity Tests
  • In vivo Biological Reactivity Tests
  • 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)

Please contact us for further information about our Biocompatibility and Toxicology Testing services. We may be able to assist you to get these testing work done for you at significantly lower cost.

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission