Good design practice for medical devices and equipment, Part I: A review of current literature

Journal of Medical Engineering and Technology

Volumn 24, Issue 1, 2000, Pages 5-13

  Alexander, K ^a   Clarkson, P J ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL ENGINEERING; DEVICE; GOOD MANUFACTURING PRACTICE; MEDICAL INSTRUMENTATION; RELIABILITY; REVIEW; SAFETY; STANDARD; VALIDATION PROCESS;

EID: 0034096069     PISSN: 03091902     EISSN: None     Source Type: Journal    
DOI: 10.1080/030919000293987     Document Type: Review

References (24)

1. 1. 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.
2. 2. US FOOD 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.
3. 3. EUROPEAN COMMITTEE FOR STANDARDIZATION, Quality systems - model for quality assurance in design/development, production, installation and servicing. EN ISO 9001: 1994 (London: British Standards Institute).
4. 4. 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).
5. 5. RHODES, I., CLARKSON, P. J., and COLVIN, B., 1994, Process development and validation: a positive approach to validation. Medical Device Technology, 5, 26-30.
6. 6. 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).
7. 7. FRIES, R. C., 1997, Reliable Design of Medical Devices (New York: Marcel Dekker).
8. 8. UK MEDICAL DEVICES AGENCY, 1998, 1997-98 Annual Report and Accounts (London: Medical Devices Agency).
9. 9. US FOOD AND DRUG ADMINISTRATION, 1998, FDA/CDRH Annual Report, Fiscal Year 1998 (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
10. 10. BOOTHROYD, G., 1996, Design for manufacture and assembly: the Boothroyd-Dewhurst experience. Design for X: Concurrent Engineering Imperatives edited by G. Q. Huang (London: Chapman & Hall), pp. 19-40.
11. 11. 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).
12. 12. EUROPEAN COMMITTEE FOR STANDARDIZATION, 1997, Medical devices-risk analysis, EN 1441: 1997 (London: British Standards Institute).
13. 13. 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).
14. 14. UK PHARMACEUTICAL INDUSTRY COMPUTER SYSTEMS VALIDATION FORUM, 1995, GAMP: Good Automated Manufacturing Practice, Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Second Draft (Brussels: International Society for Pharmaceutical Engineering).
15. 15. GLOBAL HARMONIZATION TASK FORCE STUDY GROUP 3, 1999, Process Validation Guidance Draft - February 1999 (Center for Devices and Radiological Health, Rockville, MD, USA: United States Food and Drug Administration).
16. 16. HUANG, G. Q., 1996, Design for X: Concurrent Engineering Imperatives (London: Chapman & Hall).
17. 17. BRITISH STANDARDS INSTITUTE, 1997, Guide to managing the design of manufactured products. BS 7000: Part 2: 1997 (London: British Standards Institute).
18. 18. PAHL, G., and BEITZ, W., 1996, Engineering Design: A Systematic Approach, 2nd edition (London: Springer-Verlag).
19. 19. WIKLUND, M. E., 1995, Medical Device and Equipment Design: Usability Engineering and Economics (Buffalo Grove, IL, USA: Interpharm Press).
20. 20. US FOOD AND DRUG ADMINISTRATION, 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).
21. 21. ALEXANDER, K, 1999, Design for validation of medical devices and equipment. PhD Thesis, Cambridge University Engineering Department, Cambridge University, UK.
22. 22. ALEXANDER, K., CLARKSON, P.J. and BISHOP, D., 1999, Design for validation of medical devices and equipment. Workbook (Cambridge, UK: Cambridge University Engineering Department, Cambridge University).
23. 23. WARD, J., 1998, Techniques for supporting medical device design and verification. First Year Report (Cambridge, UK: Cambridge University Engineering Department, Cambridge University).
24. 24. SHEFELBINE, S., CLARKSON, P. J., and ALEXANDER, K, 1999, Requirements capture for medical devices. Workbook (Cambridge, UK: Cambridge University Engineering Department, Cambridge University).