Medical Device & Diagnostic Industry
October 1997 MD&DI
Selected Contents
COVER STORY:
Design Control
by William J. Riley and James W. Densford III
Meeting FDA's new design control requirements need not be difficult, as informal procedures should already exist. The biggest task is finding gaps and formalizing the current system.
PRODUCT DEVELOPMENT:
Draft Revision of FDA's Medical Device Software Policy Raises Warning Flags
by Suzan Onel
FDA's draft revision to software policy threatens to impose new and more substantial documentation burdens on manufacturers.
FDA REGULATIONS:
Displaying Investigational and Unapproved Medical Devices According to FDA Policy
by Jeffrey K. Shapiro
Manufacturers need to understand FDA's policies on displaying unapproved medical devices before showing them at trade shows or on the Internet.
GLOBAL MARKETS:
Accessing the Hong Kong Medical Equipment Market
by Lauren Brosler
The recent handover of Hong Kong from Great Britain to China shouldn't affect the region's economic attractiveness to U.S. medical device manufacturers.
DESIGN CONTROLS:
How Design Controls Affect Sterilization Process Development and Validation
by Robert R. Reich
Although addressing sterilization issues at each phase of the design control process can be a burden, these steps should eliminate problems during the actual manufacturing cycle.
RISK MANAGEMENT:
Risk Management in Medical Device Design
by Henry Ozog
Evaluating potential hazards throughout the product development cycle will reduce the risk of going to market with a device that can inflict injury on a patient.
DESIGNER'S TOOLBOX:
Finding the Right Off-the-Shelf Requirements Management Tool
Several off-the-shelf tools help engineers meet design control requirements.
WASHINGTON WRAP-UP:
Industry and FDA Spar Over Labeling
by James G. Dickinson
FDA-industry debate over device labeling initiative causes dissension during HIMA workshop.
R&D HORIZONS:
Lasers Illuminate New Frontiers in Medicine
by Greg Freiherr
Medical lasers are bringing treatments to the microscopic level, mapping wounds and acting as lancets, tweezers, scissors, and more.
BOTTOM LINE:
California Home to Almost One-Fifth of U.S. Device Industry
by Daphne Allen
Nearly one-fifth of the medical device manufacturing industry calls California home, according to statistics from FDA's Division of Small Manufacturers Assistance.
HELP DESK:
Documenting a Failure Investigation
An MD&DI editorial advisory board member outlines how to document a failure investigation.
LETTERS:
Easing the Transition into China's Market
VERBATIM:
Managing A Small Company through Big Changes
Edward F. Voboril, chair and CEO of Wilson Greatbatch, talks about issues that the industry is facing, changes in his company, and how his work experience has prepared him to represent small device companies at HIMA.
SNAPSHOT:
Getting to Washington through Local Politics
by Edward E. Waldron
Washington-insider Ted Juraschek discusses the constantly changing relationship between public policy and business.
EDITOR'S PAGE:
A Preview of Coming Attractions Excellence
by John Bethune
MD&DI's editorial missionto cover the full range of issues affecting the medical device industrywill not change in 1998. Indeed, it will be reaffirmed.
1997
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1996
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