Biomedical Division Products

Quality System Regulation for Medical Devices - 21 CFR Part 820 - Final Rule

Biomedical Quality Auditor Handbook (Quality Press)

Do it By Design. An Introduction to Human Factors in Medical Devices

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Quality Press)

FDA Guide to Inspection of Quality Systems

Medical Device Reporting for Manufacturers

Quality Management 101: Back to the Basics:

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ASQ Biomedical Division Training Aids

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  The focus of this quarterly journal is to provide statistical methods for the physical, chemical, and engineering sciences. Articles describe new techniques and applications for research, development, design, and performance improvement.

Descriptions

Quality Management 101: Back to the Basics:
Presentation Re-prints from a 2 ½ day seminar describing state of the art QSR compliance. Speakers include Kimberly Trautman, Patrick Weixel, Lorelei Jarrel, Frank Gomez, Paul Brooks, Bruce Haggar, Sue Jacobs, Ken Kopesky, Daniel Olivier, Susan Reilly, and Keith Rohrbach.
Also includes 21 CFR 820 and slides from an FDA presentation on PMN and PMA.
Cost $50 plus S&H item BioCD101

Training Aids

New! Quality System Regulation for Medical Devices - 21 CFR Part 820 -Final Rule A reprint of the Federal Register notice of Oct, 1996 which includes the preamble and the complete text of the regulation. (8 ½ by 11 booklet with front and back cover) Cost $15.00 each, plus S&H item BioRD001

Do it By Design. An Introduction to Human Factors in Medical Devices
The implementation of good human factors practices in the design of medical devices is an emerging concern of great importance to the Food and Drug Administration. This document provides the information for manufacturers to improve the safety of medical devices by reducing the likelihood of user error.
Cost $15.00, plus S&H item BioDoDes

FDA Guide to Inspection of Quality Systems. A detailed guide to the FDA's new inspection process called Quality System Inspection Technique, or QSIT. The 107-page guide provides flow charts and explanations of the subsystems chosen by the FDA for inspectional focus. Cost $20 plus S&H item BioFDAGuide View Table of Contents

Medical Device Reporting for Manufacturers
A thorough description of the MDR regulation, a clear understanding of reporting responsibilities, an overview of required written MDR procedures, records and files, and information on sources for forms, instructions.
Cost $15.00, plus S&H item BioMDR