Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

IET Software

Volumn 6, Issue 5, 2012, Pages 431-437

  McHugh, M ^a   McCaffery, F ^a   Casey, V ^a  

^a DUNDALK INSTITUTE OF TECHNOLOGY   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

MEDICAL DEVICES; REGULATORY REQUIREMENTS; SINGLE POINT; SOFTWARE DEVELOPMENT PROCESS; SOFTWARE PROCESS; SOFTWARE PROCESS IMPROVEMENT; STAND-ALONE SOFTWARE;

HEALTH CARE; INDUSTRY; SOFTWARE DESIGN;

BIOMEDICAL EQUIPMENT;

EID: 84867357276     PISSN: 17518806     EISSN: None     Source Type: Journal    
DOI: 10.1049/iet-sen.2011.0198     Document Type: Article

References (48)

1. Abraham, C., Nishiharas, E., and Akiyama, M.: ' Transforming healthcare with information technology in Japan: a review of policy, people, and progress ', Int. J. Med. Inform., 2011, 80, p. 157-170 10.1016/j.ijmedinf.2011.01.002 1386-5056
2. Lee, I., Pappas, G., and Cleaveland, R.: et al. ' High-confidence medical device software and systems ', Computer, 2006, 39, (4), p. 33-38 10.1109/MC.2006.180 0018-9162
3. Leveson, N.: ' Safeware: system safety and computers ', (Addison Wesley, 1995)
4. Borrás, C.: ' Overexposure of radiation theraphy in panama ', Articles Spec. Rep., 2006, 20, (2/3), p. 173-187
5. European Council: Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, European Council, Editor, 2007
6. European Council: 'Council Directive 93/42/EEC concerning medical devices', 14 June 1993
7. European Council: 1990 'Council Directive 90/385/EEC', 5 September 2007
8. European Council: 2009 'Implementation of Directive 2007/47/EC amending Directives 90/385/EEC, 93/42/EC and 98/8/EC', 5 June 2009
9. McCaffery, F., and Coleman, G.: ' The need for a software process improvement model for the Medical Device Industry ', Int. Rev. Comput. Softw., 2007, 2, (1), p. 10-15
10. Patra, P., and Bartaki, S.: ' Productivity improvement using ten process commandments ', 2009, PMI Virtual Library
11. Jones, P.L., Jorgens, J., Taylor, A.R., and Weber, M.: ' Risk management in the design of medical device software systems ', Biomed. Instrum. Technol., 2002, 36, (4), p. 237-266 0899-8205
12. AAMI: ANSI/AAMI/IEC 62304, Medical device software - software life cycle processes, 2006
13. EN ISO 13485:2003: Medical device: quality management systems. Requirements for the regulatory process, 24 July 2003
14. EN 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability 31 May 2010
15. IEC 61010-1:2010: Safety requirements for electrical equipment for measurement, control and laboratory use, June 2010
16. ISO/IEC 90003:2003: Software engineering - Guidelines for the application of ISO 9001:2000 to computer software, February 2004
17. IEC 61508-3:2010: Functional safety of electricalelectronic programmable electronic safety related systems, May 2010
18. EN ISO 14971:2009: Medical devices. Application of risk management to medical devices, 31 July 2009
19. ISO, ISO/IEC 12207: 'Information technology - software life cycle processes' (International Organisation for Standards, Geneva, Switzerland, 1995)
20. ISO, ISO 12207:1995/AMD1:2002: International Standards Organisation, Geneva, Switzerland, 2002
21. ISO, ISO 12207:1995/AMD2:2004: International Standards Organisation, Geneva, Switzerland, 2004
22. ISO, ISO/IEC 15288:2008: 'Systems and software engineering - system life cycle processes (Geneva, Switzerland, 2008)
23. European Council, 1998: 'Council Directive 1998/8/EEC', February 1998
24. http://www.emergogroup.com/newsletters/europe-2007-47-ec-oct2007, accessed February 2011
25. European Commission: Medical devices guidance document-qualification and classification of stand alone software MEDDEV 2.1/6 2012
26. IEC 62366: Medical devices-application of usability engineering to medical devices, 13 November 2007
27. Casey, V.: ' Virtual software team project management ', J. Brazilian Comput. Soc., 2010, 16, (2), p. 83-96 10.1007/s13173-010-0013-3
28. Damian, D., and Moitra, D.: ' Global software development: how far have we come? ', IEEE Softw., 2006, 23, (5), p. 17-19 10.1109/MS.2006.126 0740-7459
29. McCaffery, F., and Dorling, A.: ' Medi SPICE development ', Softw. Proc. Maint. Evol. Improv. Pract. J., 2010, 22, (4), p. 255-268
30. O'Regan, G.: ' Introduction to software process improvement ', (Springer, 2010)
31. Messer, T., Paul, P., Paulisch, F., Schless, P., Mehner, T., and Volker, A.: ' Siemens process assessment and improvement approaches: experiences and benefits ', Twenty-second Int. Computer Software and Applications Conf., Vienna, Austria, 1998
32. Debou, C., Courtel, D., Lambert, H.B., Fuchs, N., and Haux, M.: ' Alcatel's experience with process improvement, in better software practice for business benefits: principles and experience ', (CS Press, 1999), p. 281-301
33. Basili, V.R., McGarry, F.E., Pajerski, R., and Zelkowitz, M.V.: ' Lessons learned from 25 years of process improvement: the rise and fall of the NASA software engineering laboratory ', Twenty-fourth Int. Conf. on Software Engineering, Orlando, Florida, 2002, p. 69-79
34. Daskalantonakis, M.K.: ' A practical view of software measurement and implementation experiences within Motorola ', IEEE Trans. Softw. Eng., 1992, 18, (11), p. 998-1010 10.1109/32.177369 0098-5589
35. Dyba, T.: ' An empirical investigation of the key factors for success in software process improvement ', IEEE Trans. Softw. Eng., 2005, 31, (5), p. 410-424 10.1109/TSE.2005.53 0098-5589
36. Embedded Forecasters: Embedded market forecasters survey, 2010
37. Denger, C., Feldman, R.L., Host, M., Lindholm, C., and Schull, F.: ' A snapshot of the state of practice in software development for medical devices ', First Int. Symp. on Empirical Software Engineering and Measurement, ESEM 2007, Madrid, 2007
38. Ge, X., Paige, R.F., and McDermid, J.A.: ' An iterative approach for development of safety-critical software and safety arguments ', Agile 2010, 2010
39. Walker, D.: ' CMMI and medical device engineering ', (SEI Library, 2009)
40. Burton, J., McCaffery, F., and Richardson, I.: ' A risk management capability model for use in medical device companies ', Proc. 2006 Int. Workshop on Software Quality, Shanghai, China, 2006, p. 3-8
41. McCaffery, F., and Dorling, A.: ' Medi SPICE: an overview ', J. Softw. Maint. Evol.: Res. Pract., 2010, 22, (4), p. 255-267
42. McCaffery, F., Burton, J., Casey, V., and Dorling, A.: ' Medical device industry: software process improvement, encyclopedia of software engineering ', Laplanye, P., (CRC Press Francis Taylor Group, London, 2010), p. 528-540
43. Automotive SIG: Automotive SPICE process assessment V 2.2, 21 August 2005
44. Casey, V.: ' Trust in virtual software development teams ', Special Issue and on Trust and Trust Management of the J. Theor. Appl. Electron. Comm. Res., 2010, 5, (2), p. 41-58 10.4067/S0718-18762010000200004
45. Richardson, I., Casey, V., Burton, J., and McCaffrey, F.: ' Global software engineering: a software process approach in collaborative software engineering ', (Springer, London, 2010), p. 35-56
46. ISO, ISO/IEC 15504-2:2003: Information technology - process assessment - Part 2: performing an assessment. Geneva, Switzerland, 2003
47. ISO, ISO/IEC 12207:2008: Systems and software engineering - software life cycle processes. Geneva, Switzerland, 2008
48. McCaffery, F., Casey, V., and McHugh, M.: ' How can software SMEs become medical device software SMEs ', European Systems and Software Process Improvement and Innovation Conf., EuroSPI, 2011, p. 247-258