Publications - Quality in Medical Devices

Quality in Medical Devices

Publications for the Medical Device Professional.

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


Medical Device Design and Regulation

CAPA for the FDA-Regulated Industry

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

Mastering and Managing the FDA Maze


Journal of Quality Technology

Quality Engineering

Quality Management Journal


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


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.

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Quality in Medical Devices