Expert Profile
E.J Smith
Co-Founder, Smith Associates
Is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials. E.J. is the author of Hospital Consumables and Smith's Reference and Illustrated Guide to Surgical Instruments and has 43 years of experience in medical marketing, executive positions and FDA regulatory affairs.
Trainings by Expert
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
Category:
Medical Devices
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All FDA Regulated Industry
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Marketing and Promotion
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Category:
All FDA Regulated Industry
,
FDA Audit and Inspection
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Marketing and Promotion
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Documentation and IT
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
510(k) Applications made Simple
Category:
Medical Devices
,
Risk Management
,
Marketing and Promotion
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
