A hybrid assessment approach for medical device software development companies

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Ozcan-Top Ö., McCaffery F.

JOURNAL OF SOFTWARE-EVOLUTION AND PROCESS, vol.30, no.7, 2018 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 30 Issue: 7
  • Publication Date: 2018
  • Doi Number: 10.1002/smr.1929
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Keywords: agile software development, MDevSPICE((R)), medical device software development, medical standards, process assessment, AGILE METHODS
  • Middle East Technical University Affiliated: No


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.