Verification & Validation in Medi SPICE

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

[1]  R. Bell,et al.  IEC 61508: functional safety of electrical/electronic/ programme electronic safety-related systems: overview , 1999 .

[2]  Hoyt Lougee,et al.  SOFTWARE CONSIDERATIONS IN AIRBORNE SYSTEMS AND EQUIPMENT CERTIFICATION , 2001 .

[3]  S. Atkinson,et al.  Early risk determinants and later health outcomes: implications for research prioritization and the food supply. Introduction to the workshop. , 2009, The American journal of clinical nutrition.

[4]  Cmmi Product Team.  Capability Maturity Model® Integration (CMMI), Version 1.1--Staged Representation , 2002 .

[5]  Izatul Hamimi Abdul Razak,et al.  ISO 13485:2003 , 2009 .

[6]  S. Reid.  The Art of Software Testing, Second edition. Glenford J. Myers. Revised and updated by Tom Badgett and Todd M. Thomas, with Corey Sandler. John Wiley and Sons, New Jersey, U.S.A., 2004. ISBN: 0-471-46912-2, pp 234: Book Reviews , 2005 .

[7]  Nancy G. Leveson,et al.  System safety in computer-controlled automotive systems , 2000 .

[8]  D.R. Wallace,et al.  Software verification and validation: an overview , 1989, IEEE Software.

[9]  F. Shull,et al.  A Survey of Software Engineering Techniques in Medical Device Development , 2007, 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007).

[10]  Doo-Hwan Bae,et al.  A Framework for the Vamp;V Capability Assessment Focused on the Safety-Criticality , 2005, 13th IEEE International Workshop on Software Technology and Engineering Practice (STEP'05).

[11]  Leonard Steinborn.  International Organization for Standardization ISO 9001:2000 Quality Management Systems — Requirements , 2004 .

[12]  Fergal McCaffery,et al.  A risk management capability model for use in medical device companies , 2006, WoSQ '06.

[13]  Bruno Legeard,et al.  Generation of test sequences from formal specifications: GSM 11‐11 standard case study , 2004, Softw. Pract. Exp..

[14]  Gregory Tassey,et al.  Prepared for what , 2007 .

[15]  Weiguo Lin,et al.  Software Development Practice for FDA-Compliant Medical Devices , 2009, 2009 International Joint Conference on Computational Sciences and Optimization.

[16]  Fergal McCaffery,et al.  Medi SPICE : an update , 2010 .

[17]  Mourad Debbabi,et al.  A unified approach for verification and validation of systems and software engineering models , 2006, 13th Annual IEEE International Symposium and Workshop on Engineering of Computer-Based Systems (ECBS'06).

[18]  A. Cant,et al.  A framework for assessing standards for safety critical computer-based systems , 1999, Proceedings 4th IEEE International Software Engineering Standards Symposium and Forum (ISESS'99). 'Best Software Practices for the Internet Age'.

[19]  J.J.M. Trienekens,et al.  Improving verification and validation in hardware/software environments. Introduction to the workshop , 2002, 10th International Workshop on Software Technology and Engineering Practice.

[20]  D. Richard Kuhn,et al.  FAILURE MODES IN MEDICAL DEVICE SOFTWARE: AN ANALYSIS OF 15 YEARS OF RECALL DATA , 2001 .

[21]  Thomas Thelin,et al.  An industrial case study of the verification and validation activities , 2003, Proceedings. 5th International Workshop on Enterprise Networking and Computing in Healthcare Industry (IEEE Cat. No.03EX717).

[22]  Glenford J. Myers,et al.  Art of Software Testing , 1979 .

[23]  Sanjai Rayadurgam,et al.  Test-sequence generation from formal requirement models , 2001, Proceedings Sixth IEEE International Symposium on High Assurance Systems Engineering. Special Topic: Impact of Networking.