UltraLinq Healthcare Solutions

UltraLinq Healthcare Solutions

  • Space
  • Space
  • Space

QP-7.3.0-005 Product Development Process Phase IV - Evaluation Rev 1

The Evaluation Phase covers the efforts to demonstrate Process Validation and Design Validation for the final product design which conclude the steps to completing Design Transfer from the Project Core Team to the Operations team. Relevant data and information on similar and predicate projects which may impact design or manufacturing process should be reviewed and considered by the team, as appropriate. When clinical studies are conducted to support the regulatory status of the product, they are generally conducted during Phase 4 Evaluation and their outcomes contribute to completing the Design History File for the product and gaining proper regulatory clearance in planned markets. This phase is generally concluded with a complete marketing launch plan that supports the release of the project into one or more of the intended markets.