Good design practice for medical devices and equipment, Part II: design for validation

References

• EUROPEAN COMMITTEE FOR STANDARDIZATION, 1994, Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices. EN 724:1994 (London: British Standards Institute).
   Google Scholar
• USFooD AND DRUG ADMINISTRATION, 1996,21 CFR parts 808, 812, and 820, Medical devices; current good manufacturing process (CGMP) final rule; quality system regulation. Federal Register, Vol. 61, pp. 52602–52662.
   Google Scholar
• EUROPEAN COMMITTEE FOR STANDARDIZATION, 1996, Quality systems—medical devices—particular requirements for the application of (EN) ISO 9001, EN 46001: 1996 (London: British Standards Institute).
   Google Scholar
• EUROPEAN COUNCIL, 1993, Council Directive 93/ 42/ EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities. No. L 169, 12.7.93, 1–43.
   Google Scholar
• US FOOD AND DRUG ADMINISTRATION, 1998, FDA1CDRH Annual Report, fiscal Year 1998 (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
   Google Scholar
• ALEXANDER, K., 1999, Design for validation of medical devices and equipment. PhD Thesis, Cambridge University Engineering Department, Cambridge University, UK.
   Google Scholar
• US FOOD AND DRUG ADMINISTRATION, 1996, Do it by Design: An Introduction to Human Factors in Medical Devices (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
   Google Scholar
• US FOOD AND DRUG ADMINISTRATION, 1998, Enforcement Report for December 30, 1998 (US Public Health Service, Depart-ment of Health and Human Services, Rockville, MD, USA: United States Food and Drug Administration).
   Google Scholar
• BOOTHROYD, G., 1996, Design for manufacture and assem-bly: The Boothroyd-Dewhurst experience. Design for X: Concurrent Engineering Imperatives edited by G. Q. Huang (London: Chapman & Hall), pp. 19–40.
   Google Scholar
• FRIES, R. C., 1997, Reliable Design of Medical Devices (New York: Marcel Dekker).
   Google Scholar
• WIKLUND, M. E., 1995, Medical Device and Equipment Design: Usability Engineering and Economics (Buffalo Grove, IL, USA: Interpharm Press).
   Google Scholar
• EUROPEAN COMMITTEE FOR STANDARDIZATION, 1994, Quality systems—Model for quality assurance in design/ develop-ment, production, installation and servicing, EN ISO 9001: 1994 (London: British Standards Institute).
   Google Scholar
• ALEXANDER, K., CLARKSON, P. J., and BISHOP, D., 1999, Design for validation of medical devices and equipment. Workbook (Cambridge, UK: Cambridge University Engineering De-partment, Cambridge University).
   Google Scholar
• WARD, J., 1998, Techniques for supporting medical device design and verification. First Year Report (Cambridge, UK: Cambridge University Engineering Department, Cam-bridge University).
   Google Scholar
• SHEFELBINE, S., 1998, Requirements capture for medical devices. MPhil thesis, Cambridge University Engineering Department, Cambridge University, UK.
   Google Scholar
• SHEFELBINE, S., CLARKSON, P. J. and ALEXANDER, K., 1999, Requirements capture for medical devices. Workbook (Cam-bridge, UK: Cambridge University Engineering Depart-ment, Cambridge University).
   Google Scholar
• US FOOD AND DRUG ADMINISTRATION, 1997, Design Control Guidance for Medical Device Manufacturers (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
   Google Scholar
• UK PHARMACEUTICAL INDUSTRY COMPUTER SYSTEMS VALIDA-TION FORUM, 1995, GAMP: Good Automated Manufacturing Practice, Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Second Draft (Brussels: Inter-national Society for Pharmaceutical Engineering).
   Google Scholar
• INSTITUTION OF ELECTRICAL ENGINEERS, 1990, Guidelines for the Documentation of Computer Software for Real-time and Interactive Systems, 2nd edition (London: Institution of Electrical Engineers).
   Google Scholar
• INTERNATIONAL ELECTROTECHNICAL COMMISSION, 1990, Fault Tree Analysis (FTA), IEC 61025 (Geneva: International Electrotechnical Commission).
   Google Scholar
• INTERNATIONAL ELECTROTECHNICAL COMMISSION, 1985, Analy-sis Techniques for System Reliability—Procedures for Failure Mode and Effects Analysis (FMEA), IEC 60812 (Geneva: International Electrotechnical Commission).
   Google Scholar
• KLETZ, T., 1992, HAZOP and HAZAN. Identifying and Assessing Process Industry Hazards (Rugby, Warwickshire, UK: Institution of Chemical Engineers).
   Google Scholar
• US FOOD AND DRUG ADMINISTRATION, 1995, HACCP: a State of the Art Approach to Food Safety (US Public Health Service, Department of Health and Human Services, Rockville, MD, USA: United States Food and Drug Administration).
   Google Scholar
• PIERSON, M. D. and D. A. CORLETT, JR., 1992, HACCP Principles and Applications (New York: Van Nostrand Reinhold).
   Google Scholar
• EUROPEAN COMMITTEE FOR STANDARDIZATION, 1997, Medical devices—risk analysis, EN 1441: 1997 (London: British Standards Institute).
   Google Scholar
• EUROPEAN COMMITTEE FOR STANDARDIZATION, 1996, Medical electrical equipment, Part 1: General requirements for safety, 4. Collateral standard: Programmable electrical medical systems, EN 60601-1-4: 1996 (London: British Standards Institute).
   Google Scholar
• DEMARCO, T., 1982, Controlling Software Projects: Management, Measurement & Estimation (Englewood Cliffs, NJ, USA: Prentice-Hall, Inc.).
   Google Scholar