FDA: Between process & product evaluation

Proceedings - 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability, HCMDSS/MDPnP 2007

Volumn , Issue , 2007, Pages 181-186

  Abdeen, Marwan M ^a   Kahl, Wolfram ^a   Maibaum, Tom ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARSENIC; INTEROPERABILITY; SECURITY OF DATA; TECHNICAL PRESENTATIONS;

COMMON CRITERION; EVALUATION APPROACHES; EVALUATION FUNCTIONS; GENERAL PUBLICS; GUIDANCE DOCUMENTS; MEDICAL DEVICES; MEDICAL SOFTWARES; OBJECTIVE EVALUATIONS; PROCESS EVALUATIONS; PRODUCT EVALUATIONS; PUBLIC SECTORS; QUALITY SOFTWARES; SOFTWARE QUALITIES; SOFTWARE VALIDATIONS; US FOOD AND DRUG ADMINISTRATIONS; VALIDATION APPROACHES;

COMPUTER SOFTWARE SELECTION AND EVALUATION;

EID: 48349121273     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/HCMDSS-MDPnP.2007.6     Document Type: Conference Paper

References (9)

1. Common Criteria for Information Technology Security Evaluation, part 1: Intmduction and general model, version 3.1, revision 1, September 2006.
2. Common Criteria for Information Technology Security Evaluation, part 2: Security Functional Requirements, version 3.1, revision 1, September 2006.
3. Common Criteria for Information Technology Security Evaluation, part 3: Security Assurance Requirements, version 3.1, revision 1, September 2006.
4. Common Methodology for Information Technology Security Evaluation, version 3.1, revision 1, September 2006.
5. Common Criteria for Information Technology Security Evaluation, User Guide, October 1999.
6. General Principies of Software Validation; Final Guidance for Industry and FDA staff, January 2002.
7. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA staff. May 2005.
8. Norman E. Fenton and Shari Lawrence Pfleeger, Software Metrics (2nd Ed.): A Rigorous and Practical Approach. PWS Publishing Co., 1997.
9. Victor R. Basili, Gianluigi Caldiera, and H. Dieter Rombach, The Goal Question Metric Approach, Encyclopedia of Software Engineering, Wiley&Sons Inc., 1994.