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Technical Briefs

A Small Manufacturer's Five Step Re-Think of ISO14971 for Design Control in the Post-Production Lifecycle of a Surgical Device

[+] Author and Article Information
David Herridge

Incisive Surgical, Inc.,
Plymouth MN

Manuscript received March 15, 2013; final manuscript received April 26, 2013; published online July 3, 2013. Assoc. Editor: Arthur G. Erdman.

J. Med. Devices 7(3), 030935 (Jul 03, 2013) (2 pages) Paper No: MED-13-1102; doi: 10.1115/1.4024481 History: Received March 15, 2013; Revised April 26, 2013

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References

Silverman, S., “The Case for Quality. Paper presented at: FDANEWS Medical Device Quality Congress,” May 17, 2012.
Lidwell, W., Holden, K., and Butler, J., 2003, Universal Principles of Design, Gloucester, Mass.: Rockport.
Duggan, K. J., 2012, Design for Operational Excellence: A Breakthrough Strategy for Business Growth, New York: McGraw-Hill.
Gaynes, R. P., Culver, D. H., Horan, T. C., Edwards, J. R., Richards, C., and Tolson, J. S., 2001, Surgical Site Infection (SSI) Rates in the United States, 1992–1998: The National Nosocomial Infections Surveillance System basic SSI risk index. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 33 (2): pp. S69–77.
ANSI/AAMI.HE75 Human Factors Engineering — Design of Medical Devices. 2009.
IEC. 62366 Medical Devices – Application of Usability Engineering to Medical Devices. 2007.
FDA.Understanding Barriers to Medical Device Quality. Oct. 31, 2011.

Figures

Grahic Jump Location
Fig 1

The basic risk management flowchart from for ISO14971 concludes with a feedback of production and post-production information. A critique of our design for control implementation suggested the first half of the flow chart, which feels like an FMEA, was executed stronger than the second half of the flowchart, which requires the transformation of data for the unique needs of the team performing post-market surveillance.

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