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Lessons Learned On My Sys Eng Journey

[document] Submitted on 19 February, 2019 - 15:57
Keywords eng journey lessons learned on sys eng
Standards groups

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.

Metadata
Date published
2013-01-17
Language of Attachment(s)
English
Document type
Data Item Description (DID)
Pages
28
Replaced/Superseded by document(s)
Cancelled by
Amended by
File MIME type Size (KB) Language Download
2013_01 Lessons Learned.pdf application/pdf   452.55 KB English DOWNLOAD!
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Introduction

•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.

Author(s)
Russell Kubycheck
Defines standard
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