한국건설생활환경시험연구원

Testing & Inspection of Medical Devices (Biological Safety Testing for GLP Compliance)

Full Range of Biological Safety Testing Services for GLP Compliance of Medical Devices

• Issue final GLP report in accordance with the respective testing standards for approval on medical device items
  • Common standards on the biological safety of medical devices
  • ISO 10993 testing(certain items excluded)
  • Reference standard of medical device
  • Overseas standards(USP, ASTM), etc
• GLP test-related items of medical devices
  • In vitro/in vivo genotoxicity test
  • Cytotoxicity test, blood compatibility test, endotoxin test
  • Irritation test, skin sensitization test, pyrogen test
  • Transplantation test and systemic toxicity test(subacute/subchronic toxicity & acute systemic toxicity test)

Testing & Inspection of Medical Devices (Performance/Safety Assessment)

Testing and Inspection Services Covering All 16 Categories of Medical Device & Full Technical Support at Every Stage of Product Development and Quality Control

• Testing and inspection of medical devices for approval and certification
  • Coverage of all 16 medical device categories including surgical equipment and instruments, medical equipment for external/internal insertion, and dental equipment and instruments
  • Assessment of the physical and chemical properties and performance of dental materials
  • Commissioned testing and quality inspection of medical devices
  • Validation of cle aning, sterilization, packaging, cleanliness, etc.
  • Testing of bio-burdens, microbial limits, etc
• Assessment of the R&D on Medical Device
  • Testing and assessment of research projects, support for new project development, and testing and assessment for overseas certifications
  • Assessment of the safety and performance of medical devices produced by 3D printing; support for R&D
  • Assessment for development and quality control of medical devices using new technology; support for R&D of medical devices using new technology

Non-clinical Safety Assessment for GLP Compliance & Validation of Bio-materials

Assessment of the Safety of Pharmaceuticals, Agrochemicals, Chemicals, etc. that can be Harmful to Human or Environment, and Assessment and R&D of the Safety of Veterinary Pharmaceuticals and Devices

• Non-clinical safety assessment for GLP compliance
  • Pharmaceuticals: General toxicity(incl. toxicokinetics), inhalation toxicity, genotoxicity, irritation, skin sensitization, etc.
  • Chemicals: General toxicity, inhalation toxicity, irritation, corrosion, skin sensitization, ecotoxicity, etc
  • Pesticide: Oral/dermal toxicity, irritation, skin sensitization, ecotoxicity, pesticide residual test, etc.
  • Veterinary pharmaceuticals and devices: Cytotoxicity, irritation, skin sensitization, transplantation, etc.
• Validation of Bio-materials
  • Efficacy assessment: Pharmaceuticals, health foods, functional foods, medical devices, functional cosmetics, etc.
  • Pharmacokinetics testing: Analysis of pharmacokinetics using animal specimens; analysis of bioequivalence and metabolites in biological specimens
  • Clinical and histopathological testing: Preparation and microscopic examination of slides; hematological, biochemical, and immunological testing
  • Bio-product consulting: Technical support and joint R&D for commercialization of bio-materials

Quality Control Audit of Medical Devices for GMP

Conduct GMP Audit on All Medical Device Items of Domestic and Foreign Medical Device Manufacturers

• Entity: Manufacturers and importers of medical devices
• Subject: All medical device items of Grade 2 to 4(Grade 2: Assessment by a sole quality control assessor; Grade 3 to 4: Joint assessment with a regional food and drug safety authority)
• Type
  • Initial audit: Initial audit to recognize the compliance with quality control requirements
  • Regular audit: Recurring audit(at least once every 3 year)
  • Change audit: In case the location of manufacturing facility is changed (change in the location of storage facilities or laboratories are not considered)
  • Additional audit: In case that a medical device from a different category is added to the manufacturing facility

Microorganisms, viruses, bioaerosols, & insect-repellent fields

• Sterilization, antibacterial, & antifungal testing
• Antiviral testing
• Bioaerosol reduction performance testing
  • Performance testing of air purifying products such as air purifiers, air sterilizers, HVAC, & filters for reducing airborne microorganisms(airborne viruses, airborne bacteria, & airborne mold)
• Biocide effect/efficacy testing
  • Evaluation of effectiveness/efficacy for approval of biocides according to the Consumer Chemical Products & Biocides Safety Control Act
• Testing of space surface disinfection efficacy/performance
  • Evaluation of space surface disinfection performance of space disinfection products such as disinfectants & liquid disinfectants
• Insect repellent/insecticide performance evaluation testing
  • Checking insect repellent rate and insecticidal power of materials & products
• Microbial identification & genetic analysis research
• Measurement and analysis of microbial(bacterial, mold, & viral) contamination in the field(field test)

Audit of Technical Documentation on Medical Devices

Audit the technical documentation for Grade 2 medical device certification

• Supplies(5 categories)
  • Cardiovascular equipment and instruments, surgical instruments, vision correction lenses, pharmaceutical injectors, dental materials
• Electronics(9 categories)
  • Medical tables, radiation treatment devices, physical treatment devices, cardiovascular equipment and instruments, biological condition measuring devices, medical magnetic generators, surgical instruments, vision correction lenses, pharmaceutical injectors
• In vitro diagnosis(1 category)
  • In vitro diagnosis

Medical Technology Support

Provide support for advance consulting of physical/chemical properties assessments, performance testing, biological safety testing, etc. for the medical device approval and audit

• Ongoing training and management of members depending on whether they are VIP or new members
• Specialized consulting on medical devices and their commercialization; prompt response
• Support to customized training according to the characteristics of medical devices
• Proposal and development of domestic and international standards, including ISO and KS