On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input. Some of the questions they explored were
- Is a concept phase needed for defining the product or device that meets the user needs.
- Are validation activities needed to be done during this phase (e.g., preliminary risk analysis)?
- Why is a System Requirements Specification needed?
- Who is the intended audience for System Requirements Specification?
- Which information belongs in a system requirement?
- What are the Software Requirement Specifications? Who should write them?
The Quality Injection podcast brings out the impact of system requirements on software development and test development as these high level requirements drive:
- software development planning
- software risk analysis
- software requirements generation
- design verification planning and design validation planning
- design review activities
- and more
Understanding and clarifying design input can have tremendous impact on both software development and the overall success of your medical device project. In addition to the Quality Injection podcast, see our other posts on this important topic:
Product requirements vs Software requirements
