BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Usability Studies

Usability testing is an important part of the Medical Device approval process.  The FDA recommends that the prospective device is put through a non-clinical, realistic human factors test, also known as a Usability Test.  This process should be done in addition to device design Validation, as it may not be possible to evaluate the performance of the device in use scenarios otherwise.  The ultimate goal of Usability Testing is to ensure that the device performs safely, under realistic conditions when operated by the prospective user.  This should be done with minimal training and dependence on labeling.

Biometrix provides the following services around usability testing:

  • Creation of usability tests
  • Recruitment of usability test participants
  • Execution of usability tests
  • Preparation of final reports
  • User manual testing and consulting


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Validation Services

Validation Master Plan
Autoclave Cycle Development
Validation Staffing
Validation Protocol
   Installation Qualification
   Operational Qualification
   Performance Qualification
Specification Documents
   Design Specification
   Functional Specification
   User Requirement Specification
Usability Studies
AABB Consulting


Equipment Qualification & Validation Capabilities

Autoclave Validation
Depyrogenation Oven Qualification and Validation
Lyophilizer Validation
Automated Filling Machine Validation
Filling Machine Validation
Freeze Dryer Validation
Calibration Software Validation
Centrifuge Validation
Chromatography Box Validation
Cold Room Validation
Computer Systems Validation
Environmental Chamber Validation
Environmental Room Validation
Filling Machine Validation
Freezer Validation
Glass Washer Validation
Humidity Chamber Validation
Incubator Validation
Laboratory Monitoring System Validation
Mixer Validation
Oven Validation
PLC Validation
Refrigerator Validation
Shaker Validation
Software Validation
Stability Chamber Validation
Stir Plate Validation
Stirrer Validation
Warm Room Validation


  • Biometrix Corporation
  • 301 Edgewater Place, Suite 100
  • Wakefield, MA 01880
  • www.biometrix.com
  • Tel: (978) 338-5263