We provide ISO 10993 compliant preclinical testing for medical devices, including biocompatibility studies. Our expertise supports Class A-D devices through In vivo and In vitro evaluations, ensuring patient safety and compliance with regulatory guidelines for global markets, including FDA, EU MDR, and CDSCO submissions.
- +91-877-2951279, 7013919947
- info@sugenlife.com
Medical Devices
- Acute Systemic Toxicity in mice/ Rats
- Test for local effects after implantation in rabbits/ rats
- Material mediated pyrogenicity test in rabbits
- Vaginal Irritation test in rabbits
- Penile irritation test in rabbits
- Intracutaneous reactivity test in rabbits
- Ocular irritation test in rabbits
- Skin sensitization test in guinea pigs
- Abnormal toxicity test
- Mammalian micronucleus test in mice
- Mammalian chromosomal aberration test in mice
- Ames test
- In vitro cytotoxicity
- Hemocompatibility test
- Genotoxicity test for clastogenocity in mammalian cells
- Genotoxicity test for gene mutation in mammalian cells
- Bacterial endotoxin test (by gel clot method)
- Bioburden test
- Sterility test
- Cosmetics Essential Oils
- Disinfectant
