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  CLINIMARK         Clinical Testing & Validation Services for Medical Devices

80 Health Park Dr. Louisville, CO 80027
(+US) 303-926-5432

Pulse OximetryBlood PressureRespiratory RateTemperature Additional ParametersAirway Device TestingServices

Additional Services
Usability Analysis

These Usability studies satisfy Regulatory and Risk Management requirements.

Validation Testing of Medical Devices
     ·         Overall Usability
    
·        
User Interface

Validation Testing of changes made to all types of Product Literature
     ·         Operator’s Manuals
    
·        
 Service Manuals
    
·        
Home Use Guides
     ·         Instructions For Use (IFU, DFU)

All studies include PROTOCOL DEVELOPMENT and Submission Reports

 Example reference documentation:
     ·    FDA document, An Introduction to Human Factors in Medical Devices, December 1996,
     ·    HEN136R2, Annex A, Statistical Justification for Sample Sizes in Usability Testing
     ·    FDA Guidance For Industry And FDA Premarket And Design Control Reviewers - Medical Device Use-Safety: Incorporating
          Human Factors Engineering Into Risk Management; July 18, 2000

      ·    FDA – CDRH; Office Of Health And Industry Programs: An Introduction To Human Factors In Medical
          Devices

  Publication Services Usability Analysis In Vitro Blood Lab