MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software
- 845 Downloads
Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.
KeywordsMedical Device Software Software Process Improvement Medical Device Software Process Assessment and Improvement MDevSPICE
Unable to display preview. Download preview PDF.
- 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 Google Scholar
- 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, BelgiumGoogle Scholar
- 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 Google Scholar
- 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, BelgiumGoogle Scholar
- 7.ISO, ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes. 2003, ISO: Geneva, SwitzerlandGoogle Scholar
- 8.ISO, ISO 9001:2000 - Quality Management Systems - Requirements, Geneva, Switzerland (2000)Google Scholar
- 9.IEC, IEC 62304: Medical Device Software - Software Life-Cycle Processes. 2006, IEC: Geneva, Switzerland Google Scholar
- 10.IEC, IEC TR 80002-3:2014: Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)Google Scholar