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Medical Devices (Biofouling (Solution (Surface Coating with Bioactive…

- - - - Block Adhesion of Proteins/Cells
- - - - Immediate response to tissue injury
      - Innate Immunity
      - Neutrophils, Monocytes
    - - Repair phase over months
      - Innate + Acquired Immunity
      - Macrophages, FBGCs
- - - - Compliance
        
        CE Marking
        
        Conformite Europeene
        
        Met EU health, safety, enviro requirements
        
        Consumer & Workplace Safety
        
        REQUIRED!
        
        Market Product
        
        Declaration of Conformity
      - Medical Devices
        
        Safe & Effective
        
        QA
        
        Procurement
        
        Manufacturing Process
        
        Vigilance System
        
        Classification
        
        Non-Invasive Devices
        
        Class
        
        Class 2A
        
        Low-Medium Risk
        
        Hearing Aids
        
        Short Tem Use
        
        Class 2B
        
        Medium-High Risk
        
        Infusion Pumps
        
        Long Term Use
        
        Class 1
        
        Low Risk
        
        Hospital Beds, Wheelchairs
        
        No Contact
        
        Temporary Use
        
        Invasive Devices
        
        Class
        
        Class 3
        
        High Risk
        
        Prosthetic Heart Valves
        
        Active Devices
        
        Special Devices
- - - - Cell Morphology
      - Cell lysis
      - Membrane Integrity
    - - DNA Conc
      - Protein Synthesis
      - Lysosomal Activity
      - Membrane Permeability
      - Mitochondrial Activity
- - - - 1 Day
    - - 1/>1 Dose for 2 weeks-1 month
    - - 3 Months
    - - 1/>1 Exposure to device materials