Design inputs for Medical Device — Points to Remember

  1. Design Inputs can be of these types. according to ISO13485
functional, performance, usability and safety requirements, according to the intended use
applicable regulatory requirements and standards;
applicable output(s) of risk management;
appropriate, information derived from previous similar designs;
other requirements essential for design and development of the product and processes.

2. Design inputs should be objective — It should be written in such a way that it can be tested/inspected or analysed during design verification.

3. Design inputs should not conflict with each other.

4. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

5. Design inputs should be measurable and if the device has interfaces it would be better to keep a separate usability engineering file to add usability requirements.