Risk Management Process Improvement for the Medical Device Industry

F McCaffery; D McFall; FG Wilkie

Risk Management Process Improvement for the Medical Device Industry

F McCaffery, D McFall, FG Wilkie

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

Abstract

Abstract. This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.

Original language	English
Title of host publication	Unknown Host Publication
Place of Publication	Reykjavik
Publisher	Universitatis Islandiae
Pages	92-103
Number of pages	11
ISBN (Print)	9979-54648-4
Publication status	Published (in print/issue) - May 2005
Event	International Conference on Software Development - Universiry of Iceland, Iceland Duration: 1 May 2005 → …

Conference

Conference	International Conference on Software Development
Period	1/05/05 → …

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@inproceedings{752e48ab8ce84da0a8ea9fdc07e45533,

title = "Risk Management Process Improvement for the Medical Device Industry",

abstract = "Abstract. This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.",

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note = "International Conference on Software Development ; Conference date: 01-05-2005",

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T1 - Risk Management Process Improvement for the Medical Device Industry

AU - McCaffery, F

AU - McFall, D

AU - Wilkie, FG

PY - 2005/5

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N2 - Abstract. This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.

AB - Abstract. This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.

UR - http://www.3swdc.hi.is/index.html

M3 - Conference contribution

SN - 9979-54648-4

SP - 92

EP - 103

BT - Unknown Host Publication

PB - Universitatis Islandiae

CY - Reykjavik

T2 - International Conference on Software Development

Y2 - 1 May 2005

ER -

Risk Management Process Improvement for the Medical Device Industry

Abstract

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