A Lightweight Software Process Assessment Approach Based on MDevSPICE((R)) for Medical Device Development Domain

Download

index.pdf

Date

2017-09-04

Author

Özcan Top, Özden

Metadata

Show full item record

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Item Usage Stats

197
views

84
downloads

Software process improvement is challenging in the medical device development domain, as significant constraints exist such as ensuring conformance to regulations while improving software quality. The regulations that medical products are subject to may be overwhelming for organisations as a variety of international standards have to be implemented in order to address regulatory compliance. MDevSPICE® is a framework developed to overcome this challenge by integrating different international regulatory standards’ requirements with generic software development best practices. Keeping the complexity of the domain in mind, the formal process assessments performed based on MDevSPICE® are highly detailed and require significant resource and effort investment. With the MDevSPICE® lightweight software process assessment approach, we aim to obtain maximum benefit from an assessment within a limited time by assessing all processes within MDevSPICE®, specifying and presenting major issues in projects, prioritizing such issues and progressing to the improvement stage as early as possible. The approach has designed to be a solution to improve feedback time and motivation to move forward for software process improvement actions. In this experience paper, we describe the development of the lightweight MDevSPICE® assessment method and its implementation in four companies.

Subject Keywords

MDevSPICE®, Safety critical, Regulatory requirements, Medical device software development, Lightweight assessment

URI

https://hdl.handle.net/11511/31979

DOI

https://doi.org/10.1007/978-3-319-64218-5_48

Collections

Graduate School of Informatics, Conference / Seminar

Suggestions

OpenMETU
Core

A hybrid assessment approach for medical device software development companies Özcan Top, Özden (2018-07-01) 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 fro...
An Agile business process software development methodology Çulha, Davut; Doğru, Ali Hikmet; Department of Computer Engineering (2014) An agile business process software development methodology is proposed, developed and tested in this research. To speed up the business process software development practices in the organization and to address the requirements more efficiently, an agile approach was adapted. Two new processes were developed using the new methodology. The improvement was assessed by utilizing nine older developments: A formula was developed in this research that estimates the development efforts for old business process soft...
A Software Development Process Model for Cloud by Combining Traditional Approaches Hacaloglu, Tuna; Eren, Pekin Erhan; Mishra, Deepti; Mishra, Alok (2015-10-30) Even though cloud computing is a technological paradigm that has been adopted more and more in various domains, there are few studies investigating the software development lifecycle in cloud computing applications and there is still not a comprehensive software development process model developed for cloud computing yet. Due to the nature of cloud computing that is completely different from the traditional software development, there is a need of suggesting process models to perform the software developmen...
An approach for eliciting functional requirements of the software intensive systems based on business process modeling Yıldız, Okan; Güçlü, Nusret; Demirös, Onur; Department of Information Systems (2002) In this thesis, eliciting system functional requirements based on business requirements during software intensive systems acquisition or development process is investigated and an approach is proposed for this purpose. Concepts and current problems within the framework of business requirements are investigated with a general literature review of requirements engineering and technology acquisition. Determination of requirements of IT system to be acquired according to the business objectives and base lining ...
To what extent the medical device software regulations can be achieved with agile software development methods? XP-DSDM-Scrum Özcan Top, Özden (2019-08-01) For medical device software development organizations, it is very challenging to maintain both conformance to the strict regulatory requirements enforced by the safety-critical nature of the domain and achieve efficiency in software development. Agile software development methods provide promising solutions to overcome the efficiency issues and the challenges of traditional software development approaches in the domain. Previously, we investigated to what extent the regulatory requirements defined in MDevSP...

Citation Formats

Ö. Özcan Top, “A Lightweight Software Process Assessment Approach Based on MDevSPICE((R)) for Medical Device Development Domain,” 2017, vol. 748, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/31979.