MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software

Communications in Computer and Information Science

Volumn 477, Issue , 2014, Pages 274-278

  Clarke, Paul ^a   Lepmets, Marion ^a   McCaffery, Fergal ^a   Finnegan, Anita ^a   Dorling, Alec ^a   Flood, Derek ^a  

^a DUNDALK INSTITUTE OF TECHNOLOGY   (Ireland)

Author keywords

MDevSPICE; Medical Device Software; Medical Device Software Process Assessment and Improvement; Software Process Improvement

Indexed keywords

PROCESS ENGINEERING; SAFETY ENGINEERING;

DESKTOP APPLICATIONS; HEALTHCARE SECTORS; MDEVSPICE; MEDICAL DEVICES; SAFETY-CRITICAL DOMAIN; SOFTWARE DEVELOPMENT PROCESS; SOFTWARE PROCESS ASSESSMENT; SOFTWARE PROCESS IMPROVEMENT;

SOFTWARE DESIGN;

EID: 84908529719     PISSN: 18650929     EISSN: 18650937     Source Type: Book Series    
DOI: 10.1007/978-3-319-13036-1_26     Document Type: Article

References (10)

1. FDA. FDA News on Software Failures Responsible for 24% of all Medical Device Recalls (2012), http://www.fdanews.com/newsletter/article?articleId=147391&issueId=15890 (cited April 12, 2013)
2. European Commission, Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices, in OJ o L 247 of 2007-09-21. 1993: European Commission, Brussels, Belgium
3. FDA. Chapter I-Food and drug administration, department of health and human services subchapter H-Medical devices, Part 820-Quality system regulation, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 (cited May 15, 2013)
4. European Commission, Council directive 90/385/EEC on active implantable medical devices (AIMDD). 1990: Brussels, Belgium
5. European Commission, 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
6. European Commission, Directive 2007/47/EC of the European Parliament and of the Council concerning medical devices, in OJ no L 247 of 2007-09-21. 2007, EC: Brussels, Belgium
7. ISO, ISO 13485: Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes. 2003, ISO: Geneva, Switzerland
8. ISO, ISO 9001:2000-Quality Management Systems-Requirements, Geneva, Switzerland (2000)
9. IEC, IEC 62304: Medical Device Software-Software Life-Cycle Processes. 2006, IEC: Geneva, Switzerland
10. IEC, IEC TR 80002-3:2014: Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)