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Overview
Resources
Training
Publications
Certification
Managing Supplier Relationships (PDF, 145 KB)
Standards Outlook: Ensure Medical Device Safety (PDF, 206 KB)

Publications for the Medical Device Professional.

View the latest books, journals, standards and articles on quality for the medial device industry.

BOOKS

Medical Device Design and Regulation

CAPA for the FDA-Regulated Industry

Development of FDA – Regulated Medical Products: Prescription Drugs, Biologics and Medical Devices

Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices

Mastering and Managing the FDA Maze

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

JOURNALS

Journal of Quality Technology

Quality Engineering

Quality Management Journal

STANDARDS

AAMI Quality System Standards Handbook for Medical Devices

ISO 13485:2003 Medical Devices: Quality Management Systems – Requirements for Regulatory Purposes (e-standard)

ARTICLES

Create a Lean, Mean Machine (PDF, 183KB)

Lean and Six Sigma – A One-Two Punch (PDF, 123 KB)

How to Compare Six Sigma, Lean and the Theory of Constraints (PDF, 108 KB)

This is just a small selection of the books, journals, standards and articles we have to offer! View our entire collection.