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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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