A hybrid assessment approach for medical device software development companies

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2018-07-01

Author

Özcan Top, Özden

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Medical device software development organizations are bound by regulatory requirements and constraints to ensure that developed medical devices will not harm patients. Medical devices have to be treated as complete systems and be evaluated in this manner. Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a medical device software process assessment framework called MDevSPICE((R)) that integrates the regulatory requirements from all the relevant medical device software standards. The MDevSPICE((R)) was developed in a manner that suits plan-driven software development. To improve the usability of MDevSPICE((R)) in agile settings, we extended the assessment approach. The hybrid assessment approach described here combines the MDevSPICE((R))-based process assessment method with steps for prioritization of improvement needs through value stream mapping and enabling process improvement through the use of KATA technique. This approach integrates agile methods into the medical device software development process while adhering to the requirements of the regulatory standards. This paper describes the implementation of the approach within 4 organizations that develop software in line with medical device regulations.

Subject Keywords

MDevSPICE, Medical device software development, Medical standards, Agile software development

URI

https://hdl.handle.net/11511/31917

Journal

JOURNAL OF SOFTWARE-EVOLUTION AND PROCESS

DOI

https://doi.org/10.1002/smr.1929

Collections

Graduate School of Informatics, Article

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Citation Formats

Ö. Özcan Top, “A hybrid assessment approach for medical device software development companies,” JOURNAL OF SOFTWARE-EVOLUTION AND PROCESS, pp. 0–0, 2018, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/31917.