{[ promptMessage ]}

Bookmark it

{[ promptMessage ]}

Lecture 9_Supplement

Lecture 9_Supplement - Class activity Identify one of the...

Info iconThis preview shows pages 1–10. Sign up to view the full content.

View Full Document Right Arrow Icon
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.
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
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
Background image of page 2
Internal Product Development processes (lifecycles) Rick Chapman FDA
Background image of page 3

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
Background image of page 4
Background image of page 5

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
Background image of page 6
Company Players Upper Management Middle Management Project Management Finance Legal/Regulatory Attorneys Regulatory affairs
Background image of page 7

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
Company Players Engineering Engineers Quality Assurance Designers Human Factors Scientific
Background image of page 8
Company Players Manufacturing Procurement Manufacturing Engineers Packaging Suppliers
Background image of page 9

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
Image of page 10
This is the end of the preview. Sign up to access the rest of the document.

{[ snackBarMessage ]}