Final answer:
Design Inputs describe the performance requirements a medical device must meet, including specifications and compliance with market and regulatory standards.
Step-by-step explanation:
Design Inputs are best described by D) The performance requirements that the product must meet. Design Inputs encompass all the physical, functional, and regulatory specifications of the device, detailing what a device is supposed to do and what features it must have to fulfill those needs. These include, but are not limited to, market analysis and detailed descriptions of shapes and dimensions for all components. Design Inputs do involve the Instructions For Use (IFU) but extend beyond them to include the very core functionalities and maintain the integrity of compliance with the intended use of the product. It’s essential that these inputs align with criteria and constraints that govern the quality and feasibility of the design.
The answer to this question is D) The performance requirements that the product must meet. Design Inputs in the field of engineering refer to the specific requirements and criteria that a product or device must meet in order to be considered acceptable. These can include factors such as performance specifications, dimensions, material requirements, and safety regulations. Examples of design inputs can be found in the market analysis and physical dimensions of the components.