Design verification shall confirm that the design output meets the design input requirements the results of the design verification including identification of the design method s the date and the individual s performing the verification shall be documented in the dhf g design validation.

Design inputs have been described by the fda as the most important part of the entire design control process from the fda design control guidance design input is the starting point for product design the requirements which form the design input establish a basis for performing subsequent design tasks and validating the design.

So to keep things as simple as possible we rsquo ll focus on the fda guidelines here medical design control stages from both the fda and the iso consist of design development planning design inputs design outputs design review design verification design validation design transfer design changes design history file.

Design inputs become a roadmap for the product developer design inputs describe everything that is important and required about your medical device it is 100 okay that design inputs iterate and evolve throughout the product development process.

Design inputs design inputs have been described by the fda as the most important part of the entire design control process from the fda design control guidance ldquo design input is the starting point for product design the requirements which form the design input establish a basis for performing subsequent design tasks and validating the design.

Within the design process design verification as mentioned before in the section related to the definition means demonstrating that the design outputs match the design inputs from practical point of view it means to identify specific requirements that could be related to functionality performance usability and safety of the device.

Design output 30 1 pound and 4 wheels p n 123 the fda used an example of 3 5mm as an incomplete specification but they suggested 3 500mm 0 005mm is needed however this implies more than the fda really means a design team needs to know if a 3 5mm diameter is a minimum maximum and what the purpose of the hole really is.

Design verification is where you test ldquo verify rdquo that your design outputs match your design inputs again according to the fda design verification is ldquo confirmation by examination and provision of objective evidence that specified requirements have been fulfilled rdquo.