Show/Hide Menu
Hide/Show Apps
Logout
Türkçe
Türkçe
Search
Search
Login
Login
OpenMETU
OpenMETU
About
About
Open Science Policy
Open Science Policy
Open Access Guideline
Open Access Guideline
Postgraduate Thesis Guideline
Postgraduate Thesis Guideline
Communities & Collections
Communities & Collections
Help
Help
Frequently Asked Questions
Frequently Asked Questions
Guides
Guides
Thesis submission
Thesis submission
MS without thesis term project submission
MS without thesis term project submission
Publication submission with DOI
Publication submission with DOI
Publication submission
Publication submission
Supporting Information
Supporting Information
General Information
General Information
Copyright, Embargo and License
Copyright, Embargo and License
Contact us
Contact us
How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE
Download
index.pdf
Date
2017-10-02
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
214
views
91
downloads
Cite This
Medical device software development is subject to high regulations due to the potential risk of harming patients with unsafe medical devices. These regulations require software development to be performed with high discipline and evidence to be provided for auditory purposes. It’s not easy to manage both conformance to regulations and efficiency in medical device development. Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time to market, improve customer and employee satisfaction and ensure both safety and reliability. In this study, we evaluated one of the most highly adopted agile software development methods, Scrum from a regulatory perspective. We investigated to what extend the regulatory requirements defined in MDevSPICE® are met with implementation of the Scrum method and what additional processes and practices have to be performed to ensure safety and regulatory compliance in the healthcare domain.
Subject Keywords
MDevSPICE®
,
Scrum
,
Regulatory Compliance
,
Safety Critical Domain
,
Agile software development
URI
https://hdl.handle.net/11511/30999
DOI
https://doi.org/10.1007/978-3-319-67383-7_19
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...
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...
Design strategies for the development of home use medical devices: a study on CPAP devices
Okursoy, Mehmet Erçin; Börekçi, Naz Ayşe Güzide Z.; Department of Industrial Design (2021-9-09)
Medical device development and design (MDDD) is one of the sectors with the highest level of safety regulations offering almost risk free products. Actors participating in the development process of these devices (governments, investors, non-governmental organizations, patients, etc.) not only create these highly strict regulations but also define boundaries for the design space in which design strategies are structured. These requirements eliminate suspicions over safety issues and also create a hard shell...
Why Would Opt-Out System for Organ Procurement Be Fairer?
CİVANER, MUSTAFA MURAT; Alpinar, Zumrut; Ors, Yaman (2010-01-01)
The possibility of organ transplantation has created new problems for medical ethics as well as clinical medicine. One of them, organ procurement, is tried to be solved mainly by two systems. Many countries have adopted the 'opt-in system', which aims to raise awareness and make the individuals donate their organs by their own will. The other system, 'optout' or 'presumed consent', which considers all members of society as potential donors, was adopted by some countries. In this system, individuals should s...
Challenges in Development and Implementation of Health-Risk-Based Soil Quality Guidelines: Turkey's Experience
Kentel Erdoğan, Elçin; Buyuker, Beril; Dilek, Filiz Bengü; Ipek, Meltem H.; Polat, Sener; Yetiş, Ülkü; Ünlü, Kahraman (Wiley, 2011-04-01)
Management of contaminated sites is a critical environmental issue around the world due to the human health risk involved for many sites and scarcity of funding. Moreover, clean-up costs of all contaminated sites to their background levels with existing engineering technologies may be financially infeasible and demand extended periods of operation time. Given these constraints, to achieve optimal utilization of available funds and prioritization of contaminated sites that need immediate attention, health-ri...
Citation Formats
IEEE
ACM
APA
CHICAGO
MLA
BibTeX
Ö. Özcan Top, “How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE,” 2017, vol. 770, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/30999.