Lecture 9_Supplement

Lecture 9_Supplement - Tool design Product Development...

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Class activity Identify one of the safety hazards associated with your final project. How do you plan to mitigate this hazard. Present your hazard, plan (evidence), and argument in a safety case format.
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Homework What activities from the design and development process (e.g., design control and risk management) are important for the development of a safety case? Construct a safety case for the critical hazards associated with your final project. Follow the methodology outlined in the following technical note from SEI. Charles B. Weinstock, John B. Goodenough. 2009. Towards an Assurance Case Practice for Medical Devices. SEI TECHNICAL NOTE CMU/SEI-2009- TN-018 Infusion pump specific http://www.sei.cmu.edu/reports/09tn018.pdf
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Internal Product Development processes (lifecycles) Rick Chapman FDA
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Company Players Upper Management Middle Management Project Management Finance Legal/Regulatory Attorneys Regulatory affairs
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Company Players Engineering Engineers Quality Assurance Designers Human Factors Scientific
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Company Players Manufacturing Procurement Manufacturing Engineers Packaging Suppliers
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Company Players Marketing and Sales Marketing Sales Training Technical Writers Customer User
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Product Development Phases Conceive Specification Concept design
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Product Development Phases Design Detailed design Validation and analysis (simulation)
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Unformatted text preview: Tool design Product Development Phases Realize Manufacturing Planning Manufacture Build/Assemble Test (quality check) Product Development Phases Service Sale and Deliver Use Maintain and Support Dispose Product Development Phases Concept Feasibility Design Validate Manufacture Sales End of Life Product Development Phases Idea Generation Idea Screening Concept Development and Testing Business Analysis Beta Testing and Market Testing Technical Implementation Commercialization Tools Examples Defect / Change Tracking Systems Document Mangement System On-line patent search service CAD Player Activity Phase Player Activity PHASE Concept Player Activity + Tool +++Benefit Patent Attorney Patent Search Ideas from existing patents PHASE Player Activity +++Benefit Documentation Do Whats in Red XXX-XXX Software Defects Public vs Private Automate Everything Manufacturing Engineers Product Champions Contractors and Employees Budgets Process History Project Management Lies Time Line Interpretation Patience Old guys Be Kind to Everyone Polite meetings You dont need permission to do your job When old guys roll their eyes Let people fire themselves Believe your engineers 3-way switch...
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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Lecture 9_Supplement - Tool design Product Development...

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