Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 101

We also saw that we need to document the process fully. This was suggested for two main
reasons: the first being that you may not be the final designer; the second being that you may
leave the project either intentionally or through accident. In both situations future designers
need the information stored in you head.
References
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British Standards (2001). Product specifications. Guide to identifying criteria for a product specification and to
declaring product conformity , BS 7373-2:2001.
Enderle, J., & Bronzino, J. (2011). An introduction to biomedical engineering (3rd ed.). Academic Press.
European Community (1993). Medical Devices Directive . 93/42/EC.
FDA (1997). Design control guidance for medical device manufacturers . FDA.
FDA (2010). 21 CFR Subchapter H, Part 860.
ISO (2003). BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for
regulatory purposes .
ISO (2008). ISO 9001:2008 Quality management systems .
Hurst, K. (1999). Engineering design principles . London: Arnold Publishers.
Pugh, S. (1990). Total design: Integrated methods for successful product engineering . Prentice Hall.
Ulrich, K. T., & Eppinger, S. D. (2003). Product design and development . McGraw Hill.
Webster, J. (2009). Medical instrumentation: Application and design . J Wiley and Sons Ltd.