Medical Device & Diagnostic Industry
June 1998 MD&DI
Selected Contents
COVER STORY:
Predicting Shelf Life from Accelerated Aging Data: The D&A and Variable Q10 Techniques
by John Donohue and Spiro Apostolou
With increasing requirements for predicting the longevity of medical devices kept in storage, simple methods for calculating shelf life become ever more valuable.
SENSOR TECHNOLOGY:
Micromachined Pressure Sensors Reach a New Low
by Brian Wirth
Today's noninvasive respiratory management technologies demand high-stability, ultra-low-pressure sensors.
FDA MODERNIZATION ACT:
Implementation of the FDA Modernization Act of 1997
by Jonathan S. Kahan and Howard M. Holstein
New FDA guidance documents provide insights into how device manufacturers will benefit from the new statute.
ISO 10993-10:
A Practical Guide to ISO 10993-10: Irritation
by Richard F. Wallin and Paul J. Upman
The international standard's four-tier approach to irritation testing protects patients and minimizes animal studies.
WASHINGTON WRAP-UP:
Industry Seeks to Stop FDA Budget Cuts
by James G. Dickinson
HIMA asks the House Appropriations Committee
to stabilize FDA funding from one year to the next.
R&D HORIZONS:
The Light Stuff: Optical Imaging in Medical Diagnosis
by Greg Freiherr
Optical science may light the way to radiation-free tissue analysis.
BOTTOM LINE:
Choosing a European Site
by Ed Doyle
Finding a location to open a facility is a complex but manageable process. It begins with teamwork.
HELP DESK:
Device Sterility Guidances and Validation
Timothy A. Ulatowski, director of CDRH's Division of Dental, Infection Control, and General Hospital Devices, answers questions about device sterility guidances and validation.
EMI FIELD NOTES:
International EMC Compliance Simplified
by Wayne A. Hunter and Bruce Fiorani
Selecting the right standard is crucial to attaining product certification for electromedical devices.
FIRST PERSON:Reforming Medicare: Opportunities for Change Emerge
Susan Bartlett Foote
An industry reformer urges others to add their voices to the demand for a reevaluation of Medicare's coverage process and the standards of evidence required of manufacturers.
SNAPSHOT
Tips from an Expert on Building a Start-Up
by Leslie Laine
INSIDE MD&M:
Making Science a Priority in Device Testing
by Stacey L. Bell
EDITOR'S PAGE:
Premier's Innovation Institute: To Play, Must You Pay?
by Stacey L. Bell
This new GPO's program may put the squeeze on both large and small manufacturers.
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