Define Design and Development Plan: The first step is to establish a plan that outlines the design and development activities, deliverables, and timelines. The plan should include design inputs, design outputs, and design verification and validation activities.

Design Inputs: Design inputs are the requirements that the device must meet to be considered safe and effective. Biomedical engineers must identify and document these requirements, which may include regulatory requirements, user needs, and design specifications.

Design Outputs: Design outputs are the results of the design process, such as drawings, schematics, and software code. Biomedical engineers must ensure that the design outputs meet the design inputs and are consistent with the intended use of the device.