Product Requirements Specification

January 20, 2014

Once you have established your User Needs, the Product Requirements Specification (PRS) is a technical statement of what everyone on the project team is aiming to deliver, across the whole spectrum of the project, and what the final design will be verified against.

It is much more than simply a list of product function and performance requirements, and is therefore a very detailed document.

As with most aspects of a medical device development programme, there is no single ‘one size fits all’ solution for how to manage a Product Requirements Specification, but there are some good options.

Here at Cambridge Medtech Solutions, we have a preference for using the Total Design elements by Pugh. These elements have been used very effectively on a wide range of projects over many years – although it is worth noting that in some projects, some of these elements aren’t applicable.

How does this list compare with what you consider and include in your specifications?

  • Performance
  • Environment
  • Life in Service
  • Shelf Life Storage
  • Maintenance
  • Target Product Cost
  • Competition
  • Shipping
  • Packaging
  • Quantity
  • Manufacturing
  • Size
  • Weight
  • Aesthetics, Appearance and Finish
  • Materials
  • Product Life Span
  • Standards and Specifications
  • Ergonomics, including Essential User Input
  • User
  • Quality and Reliability
  • Processes
  • Time-scales
  • Testing
  • Safety
  • Company Constraints
  • Market Constraints
  • Patents, Literature and Product Data
  • Political and Social implications
  • Legal
  • Installation
  • Documentation
  • Disposal

If you would like to know more about how to capture, understand and document your Product Requirements Specification, please contact us to discuss.