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Stage – ID4: Demonstrate the Benefits

At this stage evidence needs to be presented that the prototype is viable and meets planned design requirements. Building on this evidence, the business plan needs to be finalized and further funding needs to be sourced.

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Task Overview

Your design process should be in the final stages.

What you need to do:

  • Update the technical file and file the evidence for your design’s adoption, so you can support any future regulatory or marketing needs.
  • Conduct a detailed risk analysis on the final design, addressing any formally identified risks, and managing these risks so that they are reduced or eliminated to a point considered acceptable by end-users and any regulatory bodies.
  • The design process must be integrated into the whole product quality system with formal procedures for design control and verification, together with project planning and management. These will all contribute to any marketing or regulatory validation of the final product.
  • Convert the product design to manufacturing process design, and verify that this process meets the design input. It is vital that any changes to the final design required to make it ready for production are fed back through the risk assessment process to ensure that the final specification of the materials is based on prototype analysis, test results, and supply.
  • Consider shelf-life and how long the product will remain stable in its packaging.
  • Identify how and by whom the product should be used/not used. List the contra-indications for use to accompany the product and thereby protect the company from its misuse.
  • Add the design of the packaging, labelling, and information included with the product to the technical file.


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