ISO 10993 Biocompatibility Testing

ISO 10993 Biocompatibility Testing
Product Description

Extractables & Leachables Organic & elemental impurities Leachables in condensate Particulate Emission Volatile Organic Substances (VOC & Carbonyls) Cytotoxicity Irritation Sensitisation Material mediated pyrogenicity Acute Systemic Toxicity Subacute, Subchronic & Chronic toxicity Genotoxicity Carcinogenicity Hemocompatibility Implantation Reproductive / developmental toxicity Degradation studies

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Cormica

  • Country/Region:
    United Kingdom
  • On CPHI since:
    2024
  • Certificates:
    4
  • Employees:
    100 - 249
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Contract Manufacturer
Contract Research Organisation
Laboratory Services
Medical Devices
Regulatory Affairs
View company profile
Categories
more categories Show less

Cormica

  • Country/Region:
    United Kingdom
  • On CPHI since:
    2024
  • Certificates:
    4
  • Employees:
    100 - 249
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Contract Manufacturer
Contract Research Organisation
Laboratory Services
Medical Devices
Regulatory Affairs
View company profile

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    Product Consultancy

    Biological evaluation plans & reports (BEP & BER) Clinical evaluation plans & reports (CEP & CER) Submission support (US FDA, UK & EU MDR) Toxicological risk analysis Biological gap analysis PSUR (Periodic safety update report) Post market surveillance
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    Product Analytical Chemistry

    • GMP Release Testing Services • Product Characterisation • Occupational Hygiene Analysis • Purity Profiling & 5 Batch Studies • Extractables & Leachables • Material Characterisation • Stability Testing Services • Physico-chemical Properties • De-formulation
  • Microbiology

    Product Microbiology

    • Sterility Testing • Quality Control Release • Bioburden Testing • Method Suitability • Microbial Identification - MALDI-TOF • Bacterial Endotoxin Testing • Cytotoxicity • Environmental Monitoring • Biological Indicator Enumeration
  • Physical & Functional Testing

    Product Physical & Functional Testing

    • Combination Device Testing • Needle-based Injection System • Device Verification & Validation • Bespoke & Custom Testing • Particulate Matter Contamination • Packaging Validation & Testing • ASTM D4169 Transit Testing • ASTM F1980 Accelerated Ageing • ISO 11607 Sterile Barrier Valid...

Cormica resources (2)