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Clear SOUP and COTS Software for Medical Device Development

September 2011
11 pages
Clear SOUP and COTS Software for Medical Device Development

Medical device manufacturers may be reluctant to use COTS (commercial-off-the-shelf) because it implies SOUP (software of uncertain provenance), and thus may compromise device safety and pre-market approval by regulatory agencies. If we make the distinction between opaque SOUP and clear SOUP, that is, SOUP for which source code, fault histories and long in-use histories are available, we will find that COTS software may be the optimal choice for many safety-related medical devices.


The Usual Challenges — Deterministic and Non-deterministic Systems — Functional Safety — IEC 62304 — SOUP and Clear SOUP — Shopping for COTS Software — COTS Checklist — Conclusion [+]

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Chris Hobbs

Chris Hobbs

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). He is also a specialist in WBEM/CIM device, network and service management, and the author of A Practical Approach to WBEM/CIM Management (2004).

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.

See Also...

Fault Tree Analysis with Bayesian Belief Networks for Safety-Critical Software

Using an IEC 61508-Certified RTOS Kernel for Safety-Critical Systems

Building Functional Safety into Complex Software Systems, Part I

Building Functional Safety into Complex Software Systems, Part II

Choosing an RTOS for Remote-care Medical Devices

Persistent Publish/Subscribe Messaging in Medical Devices

Which OS for IEC 62304 Medical Systems?

Other whitepaper topics: Recent, Automotive, German Whitepapers, HMI + Graphics, Industrial, Medical, Multimedia + Acoustics, Networking, Operating Systems, Security + Defense, Safe Systems, Tools