Editor’s note: This is a two-part article. Part 1 focused on the software development.
IEC 62304 focuses on the software development process, defining the majority of the software development and verification activities. This standard outlines requirements at each stage of the development lifecycle and defines the minimum activities and tasks to be performed to provide confidence that the software has been developed in a manner that’s likely to produce highly reliable and safe software products.
Similar to other industry-specific safety standards, requirement management is fundamental for all medical-device software development. An established, verifiable requirement is essential for defining what is to be built, determining that the medical device software exhibits acceptable behavior, and demonstrating that the completed device software is ready for use. Medical devices often implement third-party software to gain specific capabilities such as Internet connectivity, USB communication, or file management without requiring the application developers to create the software needed to provide such functionality from scratch.
The use of Software Of Unknown Pedigree (SOUP) items, therefore, saves a considerable amount of time in the software development process. While IEC 62304 doesn’t discourage using SOUP items, the standard provides a process for ensuring that additional risk isn’t added to the system because of their use.
Part 2 looks at:
•Requirement Traceability and SOUP
About the authors
Anil Kumar is a technical consultant with LDRA in India, specializing in the development, integration and certification of mission- and safety-critical systems. With a solid background in development tools and real-time operating systems, Anil guides organizations in selecting, integrating and supporting their real-time embedded systems from development through to certification.
Mark Pitchford has over 25 years’ experience in software development for engineering applications, the majority of which have involved the extension of existing code bases. He has worked on many significant industrial and commercial projects in development and management, both in the UK and internationally including extended periods in Canada and Australia. For the past 10 years, he has specialized in software test and works throughout Europe and beyond as a Field Applications Engineer with LDRA.
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