Download - What is Design Assurance Engineering (DAE)?
Design Assurance
Engineering (DAE) Defined
Two DAE members and their roles in the medical device industry
Presented by:Liz Balmores
Megan McGuire
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Endovascular Therapies
http://www.patient.co.uk/diagram/Arteries-Of-The-Body.htm
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Job Titles in the Medical Device Industry:
Design Assurance Engineer Reliability Engineer Design Quality Engineer Product Quality Engineer Quality Engineer Quality Engineer – NPD
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R&D Engineers
Process Development Engineers
Regulatory
Clinical
Marketing
Project Managers
Manufacturing Engineers
Design Assurance Engineers
Operators
Technicians
Equipment & Calibration
Complaints Group
Manufacturing Quality Engineers
Packaging
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• Gage R&R Studies• Design Freeze• Design Verification• Design Validation• Biocompatibility• Competitive Testing• Shelf Life
TEST, TEST, TEST
21 CFR 820.30 Design Control Guidance for Medical Device Manufacturers
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DATA ANALYSIS
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Risk Management
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Documentation
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Why Test Methods?
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What are we testing?
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How Do We Test?
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RepeatabilityReproducibility
Test Method Validation
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Test Method Documentation
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What my parents think I do
What my fiance thinks I do What I think I do
What my friends and sisters think I do
Design Assurance Engineer
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What We Really Do:
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