Piloting MDevSPICE: the medical device software process assessment framework

Author:

Lepmets Marion1,Mc Caffery Fergal1,Clarke Paul1

Affiliation:

1. Dundalk Institute of Technology, Ireland

Publisher

ACM

Reference25 articles.

1. Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices. 1993. European Commission Brussels Belgium. Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices. 1993. European Commission Brussels Belgium.

2. Council directive 90/385/EEC on active implantable medical devices (AIMDD). 1990. Brussels Belgium. Council directive 90/385/EEC on active implantable medical devices (AIMDD). 1990. Brussels Belgium.

3. Directive 98/79/EC of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 1998. Brussels Belgium. Directive 98/79/EC of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. 1998. Brussels Belgium.

4. IEC 62304: Medical Device Software - Software Life-Cycle Processes. 2006. IEC: Geneva Switzerland. IEC 62304: Medical Device Software - Software Life-Cycle Processes. 2006. IEC: Geneva Switzerland.

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1. A hybrid assessment approach for medical device software development companies;Journal of Software: Evolution and Process;2017-12-28

2. Approach to the development of a Unified Framework for Safety Critical Software Development;Computer Standards & Interfaces;2017-11

3. A Lightweight Software Process Assessment Approach Based on MDevSPICE® for Medical Device Development Domain;Communications in Computer and Information Science;2017

4. Tailoring MDevSPICE® for mobile medical apps;Proceedings of the International Conference on Software and Systems Process;2016-05-14

5. ICSSP 2015-Special Issue Introduction;Journal of Software: Evolution and Process;2016-04-18

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