IVD compliant software development process
Pietilä, Miika (2023)
2023
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202301251636
https://urn.fi/URN:NBN:fi:amk-202301251636
Tiivistelmä
Customer was developing software for a non-regulated general laboratory devices and research use only devices. The future plan was however to develop software for In Vitro Diagnostic Devices (IVD) which are more regulated, and more requirements needs to be fulfilled in order to sell the devices in US and EU marketing areas. The main problem to be researched in the thesis was to investigate what process changes needs to be done to make the current software development process to be compliant for software developed for IVD devices. In addition to this the goal of the thesis was also to list what kind of documentation needs to be produced so that the documentation complies with all the IVD documentation requirements. The scope of the thesis was delimited to software development process related to lowest risk category IVD devices, research use only devices and general-purpose laboratory devices. Software validation and usability studies were also left out of scope but can be analysed and introduced to the process in later stages.
The methods used in the thesis was selected to be action research. The action research method allowed to analyse the background and source material in the planning stage, execute a current state analysis for the gathered material in the acting stage and finalize the process prototype in stakeholder workshops in developing stage. Finally, the final process prototype was built to the application lifecycle management (ALM) system and shared with the stakeholder and wider product development group in the reflecting stage.
The results of the thesis show that similarly structured process can be used to develop software for non-regulated and regulated software products. New process structures need to be put in place and also new documentation generated by that process needs to be implemented and preferably have document templates in place to easily fulfil the requirements. Using regulated process structure, documentation templates and hierarchy for non-regulated software also ensures that good common practices are used in both environments and are then cohesive between projects.
The methods used in the thesis was selected to be action research. The action research method allowed to analyse the background and source material in the planning stage, execute a current state analysis for the gathered material in the acting stage and finalize the process prototype in stakeholder workshops in developing stage. Finally, the final process prototype was built to the application lifecycle management (ALM) system and shared with the stakeholder and wider product development group in the reflecting stage.
The results of the thesis show that similarly structured process can be used to develop software for non-regulated and regulated software products. New process structures need to be put in place and also new documentation generated by that process needs to be implemented and preferably have document templates in place to easily fulfil the requirements. Using regulated process structure, documentation templates and hierarchy for non-regulated software also ensures that good common practices are used in both environments and are then cohesive between projects.