Resources :: Rules and Regulations
Rules and Regulations
eReader
Supplier :: eScreen Manufacturing, Phoenix, Arizona
Single manufacturing facility for the eReader device. 100% Final Testing performed
on units prior to shipment to eScreen warehouse. Certificate of compliance issued with every eReader stating that device
has been manufactured and tested in accordance with eScreen specifications.
eCup
Supplier :: eScreen Manufacturing, Phoenix, Arizona
FDA registered, therefore all eCups are manufactured under CGMP and QSR requirements.
All components of the eCups are from qualified suppliers. A certificate of compliance is
required for all critical components. A receiving inspection is performed on all eCups
components to ensure critical measurements and performance are within specified tolerances; parts are clean and free from
embedded particulate. In-process inspections are performed regularly during manufacturing. Final QC inspections are
performed prior to shipment to eScreen clinics. Every design, material or manufacturing change to the eCup
is validated in order to determine if there will be any effect on eReader test interpretation.