Comparison of Requirements Management Solutions for Medical Device Development
Virtanen, Taneli (2020)
2020
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202003173528
https://urn.fi/URN:NBN:fi:amk-202003173528
Tiivistelmä
This Bachelor’s thesis was commissioned by Thermo Fisher Scientific Oy and it aims to study and compare requirements management tools for their medical device development at their Vantaa location. Their medical device portfolio focuses on IVD-devices and medical laboratory automation products. The scope of this thesis was limited to comparing Polarion ALM to the current requirements management solution, evaluating capabilities of the software tools in the extensively regulated medical device industry and identifying possible process improvements.
The identified problems with the current methods and tools were compiled as a problem statement and possible mitigative solutions addressed in the comparisons, evaluating the capabilities of Polarion ALM as the replacement for IBM Rational DOORS. In addition, process improvements and possible changes enabled by adopting a new lifecycle management tool as the requirements management solution were identified and classified based on their impact on the current working processes.
In conclusion, Polarion ALM was found a capable tool and ready to implement to the current working processes relatively seamlessly while simultaneously addressing multiple problems identified with the currently used tools. In addition, the versatile nature of Polarion ALM and its revisioning, traceability and visualization features were identified to facilitate gradual implementation of process improvements towards a more agile and modern environment in software based medical device development.
The identified problems with the current methods and tools were compiled as a problem statement and possible mitigative solutions addressed in the comparisons, evaluating the capabilities of Polarion ALM as the replacement for IBM Rational DOORS. In addition, process improvements and possible changes enabled by adopting a new lifecycle management tool as the requirements management solution were identified and classified based on their impact on the current working processes.
In conclusion, Polarion ALM was found a capable tool and ready to implement to the current working processes relatively seamlessly while simultaneously addressing multiple problems identified with the currently used tools. In addition, the versatile nature of Polarion ALM and its revisioning, traceability and visualization features were identified to facilitate gradual implementation of process improvements towards a more agile and modern environment in software based medical device development.