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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