The design output is all of the evidence that the design input requirements have been met.

This should include risk assessment for the following:

• Both the design and process
• Assembly drawings
• Component and raw material specifications
• Work instructions for the assembly process
• Instructions for service and installation
• Packaging and labeling specifications
• Any biocompatibility studies
• Results of verification activities
• Software source code
• Technical files
• Any completed validation activities, such as sterility, shipping, reliability testing or shelf-life studies

Realized Product

The design output is also the first realized product, which may be the initial lots of product manufactured or the first set of several assemblies depending on the nature of the product.

The first series of realized product undergoes an evaluation of all the output criteria as well as a comparison of the different lots or serial numbers to evaluate the consistency of the processes. This is the design validation which we will discuss later in this course.

Design Reviews

It is important to have a formal design review process to document design review activities.

The design review is a comprehensive, documented, systematic evaluation of the design to evaluate the adequacy of the design requirements and the capability of the design to meet those requirements and to identify problems and implement corrective actions to those problems.

Progress and Emerging Problems

Design reviews are often used at specific stages of the design process, but also may be held at other times such as to assess project progress, or provide feedback or notification of emerging problems.

The DDP will often dictate specific milestones which are typically documented as a design review.

The number of design reviews which occur will be dependent on the organization and the complexity of the product.

Design Freeze

For a very simple product there might only be a single review at the conclusion of the development process which would freeze the design.

For a more complex product, and specifically one with many interfaces and multiple subsystems there are likely to be several review phases to ensure that all the subsystems and interfaces are going to work with one another.

The design review post, device development is typically referred to as the “design freeze”.

The design freeze, establishes a key milestone in the design control process where design changes can no longer be made without a formal design change.