Very few tier 1 suppliers in the world for aircraft.
–Many interfaces to align
–Many sub-contractor efforts to define and later integrate.
-DoD start SE in 1940(s) for the development of missiles and missile-defense systems.
Replaced/Superseded by document(s)
•Many companies making medical devices
•The FDA mandates Design Control for medical devices in 1997.
•Current device development driven by requirements of Design Control for the goal of FDA approval.
•FDA has mandated higher and higher thresholds for product safety and effectiveness.
•Product safety is now capture by assurance cases.