Changes
/* Potential DHF Review Outcomes */
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.
# Change in raw materials to better grade materials for ege.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.
# Updating drawings based on results from the FAI data.
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.
