In this phase the product and all of the designed subsystems and components are implemented with the selected technologies and, at the end of the phase, tested to the PRS. The claims made in the PRS are tested and objectively verified (and documented); this verification shows that "the product was designed correctly".

The manufacturer selection process will be started and the preliminary manufacturing processes and tests are in design.

Once all the subsystems and components (whether constructed or procured, are verified through the Engineering Verification Tests - EVT) the final Integration and testing through the Design Verification Tests DVT) can begin (see: Product testing? Why? …and How Much? ; The Realms of Testing during the life of a product ).

Some design and test creativity takes place here, but only if required and approved through the change control mechanism.

Again, prototype as often as possible - you get a better product… faster.

• Procure specified components and subsystems
• The manufacturing (and other required) processes are developed for the subsystems. (MDOC)
• Prepare preliminary Manufacturing test & QA procedures and validate as required (especially medical products) (MTR2)
• Assembly Drawings (DDOCS), (MDOC)
• Gerber files - pin lists (DDOCS), (MDOC)
• Fabrication Drawings (DDOCS), (MDOC)
• BOMS/AVLS (DDOCS), (MDOCS)
• Procurement Drawings (DDOCS), (MDOC)
• Wire-frames (DDOCS), (MDOCS)
• Flow charts and State diagrams (DDOCS), (MDOCS)
• Prepare preliminary manufacturing documentation (MDOC)
• Prepare procurement documentation for specified components (MDOC)