Abstract
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.
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References
Abraham, C., Nishiharas, E., Akiyama, M.: Transforming healthcare with information technology in Japan: A review of policy, people, and progress. International Journal of Medical Informatics 80(3), 157–170 (2011)
Lee, I., Pappas, G., Cleaveland, R., Hatcliff, J., Krogh, B., Lee, P., Rubin, H., Sha, L.: High-Confidence Medical Device Software And Systems. Computer 39(4), 33–38 (2006)
European Council, Council Directive 2007/47/EC (Amendment). In: Official Journal of The European Union: Luxembourg (2007)
European Commission, MEDICAL DEVICES: Guidance document- Qualification and Classification of stand alone software (MEDDEV 2.1/6). Brussels, Belgium (2012)
US FDA Center for Devices and Radiological Health, General Principles of Software Validation; Final Guidance for Industry and FDA Staff. CDRH: Rockville (2002)
US FDA Center for Devices and Radiological Health, Off-The-Shelf Software Use in Medical Devices; Guidance for Industry, medical device Reviewers and Compliance. CDRH: Rockville (1999)
US FDA Center for Devices and Radiological Health, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. CDRH: Rockville (2005)
US FDA, 21 CFR Part 880 Medical Devices; Medical Device Data Systems Final Rule. Federal Register, 2011. vol. 76(31), pp. 8637 – 8649 (2011)
US FDA, Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications (2011)
Vogel, D.A.: Medical Device Software Verification, Validation and Compliance, p. 432. Artech House, Norwood (2010)
IEC 62304:2006, Medical device software—Software life cycle processes. IEC: Geneva, Switzerland (2006)
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes. ISO: Geneva, Switzerland (2003)
ISO 14971:2007, Medical Devices — Application of risk management to medical devices. ISO: Geneva, Switzerland (2007)
BS EN 60601-1:2005Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC: Geneva, Switzerland (2005)
IEC 62366:2007, Medical devices - Application of usability engineering to medical devices. IEC: Geneva, Switzerland (2007)
IEC 60812:2006, Analysis technique for system reliability - Procedure for failure modes and effects analysis (FMEA). IEC: Geneva, Switzerland (2006)
IEC/TR 80002-1:2009, Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software. BSI: London (2009)
IEC/TR 61508:2005, Functional safety of electrical/electronic/ programmable electronic safety related systems. BSI: London (2005)
Mc Caffery, F., Burton, J., Casey, V., Dorling, A.: Software Process Improvement in the Medical Device Industry. In: Laplante, P. (ed.) Encyclopedia of Software Engineering, pp. 528–540. CRC Press Francis Taylor Group, New York (2010)
Denger, C., Feldmann, R., Host, M., Lindholm, C., Shull, F.: A Snapshot of the State of Practice in Software Development for Medical Devices. In: First International Symposium on Empirical Software Engineering and Measurement, Madrid, Spain (2007)
Mc Caffery, F., Dorling, A.: Medi SPICE: An Overview. In: International Conference on Software Process Improvement and Capability Determinations (SPICE), Finland (2009)
Casey, V., Mc Caffery, F.: Med-Trace: Traceability Assessment Method for Medical Device Software Development. In: European Systems and Software Process Improvement and Innovation Conference. Roskilde University, Denmark (2011)
CMMI Product Team, Capability Maturity Model Integration for Development Version1.3. Software Engineering Institute, Pittsburg PA (2010)
ISO/IEC 15504-5:2012, Information technology - Process Assessment - Part 5: An Exemplar Software Life Cycle Process Assessment Model. ISO (2012)
Mc Caffery, F., Dorling, A.: Medi SPICE Development. Software Process Maintenance and Evolution: Improvement 22(4), 255–268 (2010)
Automotive SIG, Automotive SPICE Process Assessment V 2.2 (August 21, 2005)
IEC/CD 82304:2014, Health Software - Part 1: General Requirements for Product Safety. ISO: Geneva, Switzerland (2014)
IEC/TR 80002-3:2014, Medical Device Software - Part 3: Process reference model for medical device software life cycle processes (IEC 62304). ISO: Geneva, Switzerland (2014)
ISO/IEC 12207:2008, Systems and software engineering - Software life cycle processes. ISO: Geneva, Switzerland (2008)
ISO/IEC 15504-2:2003, Software engineering - Process assessment - Part 2: Performing an assessment, ISO: Geneva, Switzerland (2003)
Mc Caffery, F., Dorling, A., Casey, V.: Medi SPICE: An Update. In: International Conference on Software Process Improvement and Capability Determinations (SPICE), Pisa, Italy (2010)
Casey, V.: Virtual Software Team Project Management. Journal of the Brazilian Computer Society 16(2), 83–96 (2010)
Mc Caffery, F., Richardson, I., Coleman, G.: Adept – A Software Process Appraisal Method for Small to Medium-sized Irish Software Development Organisations. In: European Systems & Software Process Improvement and Innovation (EuroSPI 2006), Joensuu, Finland (2006)
Mc Caffery, F., Casey, V.: Med-Adept: A Lightweight Assessment Method for the Irish Medical Device Software Industry. In: European Systems & Software Process Improvement and Innovation Conference (EuroSPI), Grenoble, France (2010)
Casey, V., Mc Caffery, F.: A lightweight traceability assessment method for medical device software. Journal of Software Maintenance and Evolution Research and Practice (2011)
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McCaffery, F., Clarke, P., Lepmets, M. (2014). A Lightweight Assessment Method for Medical Device Software Processes. In: Mitasiunas, A., Rout, T., O’Connor, R.V., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2014. Communications in Computer and Information Science, vol 477. Springer, Cham. https://doi.org/10.1007/978-3-319-13036-1_13
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DOI: https://doi.org/10.1007/978-3-319-13036-1_13
Publisher Name: Springer, Cham
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