Medical Device & Diagnostic Industry

August 1997 MD&DI
Selected Contents

COVER STORY:
Complying with the Quality System Regulation and ISO 11607
by Denis G. Dyke
By identifying the optimum time frame for each key process variable, validation achieves process control and ensures that package requirements are met.

COMPLIANCE TESTING:
EMI Testing in Medical Electronics
by William D. Kimmel and Daryl D. Gerke
Although electromagnetic compatibility compliance testing is a necessary time and cost expenditure, manufacturers can save themselves much of the hassle of this final stage by doing in-house precompliance testing and troubleshooting.

STERILIZATION:
The Effects of High-Energy and EtO Sterilization on Thermoplastics
by Nancy J. Hermanson, Lisa Navarrete, and Pat Crittenden
Selecting the proper resin for an application can depend on the sterilization method to be used on the device.

WASHINGTON WRAP-UP:
FDA Confronts Mutual Recognition Reality
by James G. Dickinson
Disgruntled FDA and EU officials couldn't reconcile differences before the scheduled May 28 signing of the mutual recognition agreement, and they face significant problems in the three-year transition ahead.

DESIGNER'S TOOLBOX:
Time-Lapse Video Offers More Information in Less Time
by Stephen B. Wilcox
Using time-lapse video compresses lengthy documentation, providing designers with quantitative data more quickly.

R&D HORIZONS:
Micromachines Making Headway in Medical Applications
by Greg Freiherr
Fighting to switch the industry focus away from automotive applications, medical-use micromachines are introducing some amazing new technologies that are cheaper than their standard-size counterparts.

LETTERS:
Specialty Distributors Promise Sales and Efficient Distribution

BOTTOM LINE:
Ten Techniques for Trimming Time to Market
by Daniel P. Olivier
Savvy companies can keep up with rapidly changing regulatory requirements and still streamline processes in product development.

HELP DESK:
Effective Training for New Manufacturing Employees
Clarence Semple, president of Sigma Four (Redondo Beach, CA), a usability engineering firm, explains how to best design, develop, and evaluate a cost-effective manufacturing training program.

VERBATIM:
Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform
An interview with Kevin Murray, director of regulatory affairs and communications at Medical Devices Canada (MEDEC).

SNAPSHOT:
Taking Wing: A New Corporate Name for a New Era in Health Care
by Edward E. Waldron
William Mercer is helping Alaris ascend to new heights.