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an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, p y pp intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Sorenson Medical, West Jordan, Utah USA
3.
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Design Control
Design & Development Planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file
Sorenson Medical, West Jordan, Utah USA
5/20/2010
User Needs
what & why stated in user terms
Marketing Requirements
measurable, engineering terms
Traceability Analysis
T A SE P AE RNFR HS
Design Review
Traceability Analysis
Risk Analysis
Manufacturing Transfer
Traceability Analysis A l i
Design Review
Product Specifications
Design Review
Traceability Analysis
Design Review
F A DS N P AE IN L E IG HS
Traceability Analysis
Prototype Design
Design Validation
Finalize Documentation
Design Review
Design Input
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Design Concept
Risk Analysis
Failure mode Potential effects Severity
1 to 10 (negligible to potential for multiple deaths)
Risk
Likelihood / severity matrix
Mitigation
Sorenson Medical, West Jordan, Utah USA Sorenson Medical, West Jordan, Utah USA
5/20/2010
5/20/2010
Validation
5/20/2010