22.06.2010

Managing Product Variants for Medical Devices

Mrs. Dr. Anne Kramer speaks at the SPICE Days 2010

You are welcome to visit the Session 1, on 22 Juny 2010 at 11:00 am (OG2/Room Reutlingen).

Abstract:
In this talk we present major difficulties that are related to the development process for IT product variants. Managing product variants in use cases, requirements, source code and test is a complex task. These difficulties are enforced by high process standards that are mandatory for the development of software for medical devices.
The only way to obtain maintainable, reusable code and to limit the impact of modifications is to separate variant-specific parts properly from the rest – and this right from the start, i.e. at architectural level. Using models is a good way to visualize the dependencies between common functionality (domain engineering) and variant-specific parts (application engineering). Models also establish a comprehensive link between use cases, requirements and tests.
The major difficulty in testing product variants consists in providing a proof that no relevant test has been forgotten (for regulatory and general quality reasons) without testing more than strictly necessary (for economical reasons). Again, test design models are a powerful and efficient tool to specify and manage tests of product variants.

Domain
variants management, requirements engineering, requirements tracing, test design models

Topic
How to solve key SPICE topics?