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Biocompatibility Assays

By following the increasing size of ageing population and elevated living standard, the demand for medical devices has been significantly increasing. To secure the safety and quality for medical treatment, the Ministry of Health and Welfare, Taiwan has published the Medical Device Management Act – medical devices which contacts human physical surface should undertake the biocompatibility assays by following ISO10993 to complete the examination and registration procedures. MedGaea Life Sciences Ltd (MDG) possesses quality assurance systems such as Taiwan Accreditation Foundation (TAF) accredited OECD-GLP, ISO17025 and TFDA accredited GLP etc., as well as self-owned animal facility. Biological Laboratory Team Members are familiar with Biocompatibility regulations such as ISO10993, ASTM and USP, and successfully assist domestic medical device manufacturers to successfully obtain registration from Taiwan TFDA, US FDA (510K), Korean KFDA, European Union CE and so on. Medical device product range we have tested includes orthopedic and dental implants, tracheostomy tubes, intravascular administration set, syringes, contact lens, surgical instruments, medical textile, wound dressing, catheters and consumables, and mechanical ventilators. Our study directors are professional in replying inquiries in regulatory issues

  • In Vitro Cytotoxicity Test
  • Oral mucosal irritation test
  • Skin Sensitization Test
  • Intracutaneous Irritation test
  • Ocular Irritation test
  • Hemolysis Test
  • Pyrogen Test
  • Endotoxin Test
  • Salmonella Reverse Mutation Test (Ames test)
  • In vitro (italic)
  • Rodent Micronucleus Test with Peripheral Blood
  • Acute Systemic Toxicity test
  • Sub-acute/ sub-chronic toxicity study
  • (Muscle, subcutaneous, or bone) implantation study in rabbit or swine
  • Wound Healing Assay
  • Burn and Scalds Assay
  • Other functional validation and customized assays
  • Ethylene Oxide (EO) residue test
  • Accelerated Aging Test
  • Microbiological detection