The Design Process - Medical Device Design: Innovation from Concept to Market - page 51

here we saw that each individual aspect of the design is in itself another divergent-convergent
process (ensuring that the best outcome is achieved).
We were then introduced to a number of models that help us to manage the design process.
We saw that we need to accommodate iterations in our design and that we should incorporate
the thoughts of others as early as possible. We also saw that through the use of modern
technology, we are able to work collaboratively with our stakeholders, thus making a holistic,
inclusive approach highly viable. Or, to coin a phrase, you want your band to be playing the
same tune as you - all the way through the concert.
Tasks
1) Make sure you get copies of:
the FDA document Design Control Guidance for Medical Manufacturers
ISO 13485
2) Read and digest the FDA guidelines and Section 7.3 of the standard.
3) Map Section 7.3 of ISO 13485 with the FDA guidelines.
References
Bicheno, J., & Catherwood, P. (2005). Six sigma and the quality toolbox . Buckingham: PICSIE Books.
FDA (1997). Design control guidance for medical device manufacturers . FDA.
ISO (2003). BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for
regulatory purposes .
ISO (2008). ISO 9001:2008 Quality management systems .
Pahl, G., Beitz, W., Feldhusen, J., & Grote, K. H. (2007). Engineering design: A systematic approach . London:
Springer Verlag.
Pugh, S. (1990). Total design: Integrated methods for successful product engineering . Prentice Hall.
Schrwazenbach, J., & Gill, K. (1992). System modeling and control . Butterworth-Heinmann.
Wikipedia (2011). Newton's method . Cited 13.06.11. http://en.wikipedia.org/wiki/Newton's_method.
Further Reading
Bruce, M., & Bennant, J. (2002). Design in business: Strategic innovation through design . Harlow: Prentice Hall.
George, M. L., Maxey, J., Rowlands, D. T., & Upton, M. (2005). The lean six sigma pocket toolbook . McGraw
Hill.
Hurst, K. (1999). Engineering design principles . London: Arnold Publishers.
Jones, T. (2002). Innovating at the edge . Oxford: Butterworth Heinmann.
Ulrich, K. T., & Eppinger, S. D. (2003). Product design and development . McGraw Hill.