Medical Device
Designated by the Ministry of Food and Drug Safety as a medical device testing and inspection body, technical documents review body and quality management assessment body, KCL performs testing and inspection of medical device, assessment of technical documents and quality management system audit (GMP).
Testing of medical device
- Testing and inspection for approval of medical device (manufactured and imported equipment)
- Consignment testing for the voluntary quality control of manufacturers and importers (residual EO gas testing, sterility testing, etc.)
- Biocompatibility testing for international certification by the FDA (U.S.), CE (Europe), etc.
- Testing for technology support such as accelerated aging test for establishing term of Expiration date, sterilization validation, packaging and clean room validation
Test Areas
- Cytotoxicity test
- Acute systemic toxicity test
- Pyrogen test
- Intracutaneous reactivity test
- Hemolysis test
- Implantation test
- Bacterial reveres mutation test
- In vitro mammalian chromosome aberration test
- Mammalian erythocyte micronucleus test
- Sub-acute and sub-chronic toxicity testing
Other tests
- Antibacterial test and sterilization test for medical device and Consumer products
- Bioburden testing of products
- Efficacy evaluation (performance evaluation in vitro and various animal models)
- Manufacturing of tissue slides (tissue treatment, embedding, paraffin block)
- Staining (immunohistochemistry, immunofluorescence, special stain, etc.)
Review of technical documents
- Review of technical documents on class 2 medical device
- New review: Within 25 days; Review of change: Within 15 days
