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Test Development Process
Test development activities
follow documented procedures. Processes have
been refined from experiences to meet relevant
standards such as ISO9001-2000, TL9000, EN46001
and FDA medical device standards.
Test Development Process Overview
Development activity is focused on test
requirement analysis and documentation in the
form of a test specification. Design
Verification activities included design reviews
at key points during the design. Reviews include
organized review by peers of the hardware,
fixture, and software associated with this test
development. The reviews and other key
activities are called out in a project plan. As
an ISO9001 company, projects are not complete
without a validation process. A Test Plan is
written, approved, and implemented to fulfill
the validation phase.
Documentation Diagram
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