In addition to the usual software delivery challenges of cost, features and schedules, medical device manufacturers must contend with specifying and validating their products’ functional safety, as well as with achieving certification by the FDA and other regulatory agencies. Many manufacturers consider COTS (Commercial-off-the-Shelf) software to reduce development times and problems, but are concerned that by using COTS they will be using SOUP (Software of Uncertain Provenance), which will invalidate their products’ functional safety claims and make certification impossible.

This presentation reviews common misconceptions about COTS and SOUP, and explains what is meant by clear SOUP. It then provides an overview of conditions that COTS software must meet in order to qualify for clear SOUP, and thus be admissible for use in a medical device. Finally, the presentation describes and explains how to evaluate key items when considering COTS software for a safety critical system:

  • functional safety requirements
  • architecture
  • fault histories
  • development techniques
  • validation processes

Estimated length: 1 hour, including Q&A

Who should attend?

The seminar is intended for design managers and engineers, product and project managers and software developers and engineers in companies planning to design and build equipment for the healthcare and medical market.

Prerequisites: There are no prerequisites for this session.


Chris Hobbs, Senior Developer—Safe Systems, QNX Software Systems
Chris Hobbs is a kernel developer at QNX, specializing in “sufficiently-available” software: software created with the minimum development effort to meet the availability and reliability needs of the customer; and in producing safe software (in conformance with IEC61508 SIL3). In addition to his software development work, Chris is a flying instructor, a singer with a particular interest in Schubert’s Lieder, and the author of several books, including Learning to Fly in Canada (2000) and The Largest Number Smaller than Five (2007). His blog, Software Musings, focuses “primarily on software and analytical philosophy”.

Chris Hobbs earned a B.Sc., Honours in Pure Mathematics and Mathematical Philosophy at the University of London’s Queen Mary and Westfield College.

Moon, Product Manager, Medical, QNX Software Systems

Justin Moon is
currently a Product Manager for the medical market. Since joining QNX Software
Systems 10 years ago, Justin has worked on the Custom Engineering Team,
specializing in BSP and driver development, and on the Automotive Team, where he
worked with a number of Tier 1 and OEM automotive companies. He has also worked
as a Field Application Engineer responsible for QNX’s Canadian customers.