Notes

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¹ Bringing New Products to Market; Hall, John A.; 1991; AMACOM; How To Develop Successful New Products, Patrick, Jerry, 1997, AMA; Building Excellence in Software Product Development Management, Kormos, Joseph

² E.g. Quality Function Deployment, a method to transform the language of the customer into the language of the engineer; Conjoint Analysis, the application of design-of-experiments to obtain individual customer preferences; The Product Development and Management Association, http://www.pdma.org/

³ FDA's Quality System Regulation, 21 CFR 82, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1; Software Requirements, Faulk, S.R., In Software Engineering, IEEE Computer Society Press, Los Alamitos, CA, 1997; IEC60601-1-4

⁴ General Principles of Software Validation; Final Guidance for Industry and FDA Staff http://www.fda.gov/cdrh/comp/guidance/938.pdf

⁵ Managing Creativity: A practical Guide to Inventing, Developing and Producing Innovative Products; Donna Shirley; http://www.donnashirley.com/; Donna Shirley was the manager of the Mars Exploration Program and the original leader of the team that built the Sojourner Rover.

⁶ See for example: Target Setting: Key to Successful NPD Outcomes, John J. Dutton, Director of New Product Development Services, Arthur Andersen LLP, http://www.pdma.org/visions/apr98/dutton.html

⁷ http://www.qfdi.org

⁸ Patterned after the Staged-Gate methodology, developed by Robert G. Cooper. This is widely accepted as a highly effective, formal new product development process to increase the chances of a product's success. http://www.qualisci.com/default.asp?AD=5

⁹ E.g. ANSI/ISO/AQS, NASA, FDA, MDD, Auto and aircraft manufacturers, IEEE

¹⁰ ISO9000,http://www.iso.ch/; QS9000, http://www.asqc.org/; EN29000, http://www.cenelec.be/; BS5750, http://www.bsi.org.uk/; IEC, http://www.iec.ch/; IEEE Std 1012-1998, http://standards.ieee.org/; FDA QSR 21 CFR Part 820, http://www.fda.gov/cdrh/comp/designgd.html; ISO 14000 Environmental Management Standard, http://www.iso14000.com/

¹¹ Metrics and Models In Software Quality Engineering, Kan, Stephen H., Addison-Wesley, 1995; Sizing Up Software, Jones, Casper, Scientific American, Dec 1998, pp. 104-109

¹² The FDA calls this the "Design History File (DHF)"

¹³ http://www.pdmic.com/unPRStnd.html

¹⁴ The FDA calls this the "Device Master Record (DMR)" and the CE mark calls this the "Technical File"

¹⁵ Hall, John A. IBID; Patrick, Jerry IBID