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Accessing the Hong Kong Medical Equipment Market

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI October 1997 Column GLOBAL MARKETS Economic strength combined with lax guidelines for medical device imports make Hong Kong a ripe target. Its commercial sector well versed in the ways of the...

How Design Controls Affect Sterilization Process Development and Validation

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI October 1997 Column DESIGN CONTROLS Design control demands that all factors affecting a product's performance be considered before production. For sterile medical devices, that means the...

Risk Management in Medical Device Design

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI October 1997 Column RISK MANAGEMENT Early and continuous evaluation of a product's hazard potential increases the likelihood of correcting these faults and producing a device with a low probability of causing harm.

Getting to Washington through Local Politics

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI October 1997 Column SNAPSHOT Ted Juraschek and Bill Clinton have at least one thing in common: They both began an important phase of their careers in January 1993 in Washington, DC. Juraschek is...

An Awards Program Dedicated to Medical Design Excellence

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column An awards program exclusive to the device industry can serve to increase the visibility not only of the winning companies, but also of the industry as a whole. If you've...

Managing Software Risk

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column To the Editor: The June 1997 cover story, "Software Risk Management: Not Just for the Big Manufacturers?" by John Suzuki and Dale W. Karolak, was excellent, but the authors made...

Using Statistical Analysis in Device Testing

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column To the Editor: In the June 1997 article by Thom R. Nichols and Sheldon Dummer, "Assessing Pass/Fail Testing When There Are No Failures to Assess," the authors assume a two-sided...

Innovation Is Key to Motivating Change in Health Care

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column FIRST PERSON For the assistant director of SRI International (Arlington, VA), complying with regulatory issues is but a sliver in creating a winning device. Health care...

Rapid Tooling Provides Molded Parts Early in Development Cycle

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column DESIGNER'S TOOLBOX Designers often need to develop parts early to determine which materials will maintain necessary tolerances in manufacturing complex devices....

Historic MRA Signed with Europe

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column WASHINGTON WRAP-UP There is plenty of work left to do on the U.S.European Union mutual recognition agreement. James G. Dickinson On June 21 the U.S.European Union...

Implantable Pumps Improve Drug Delivery, Strengthen Weak Hearts

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column R&D HORIZONS Complete pump systems may someday replace damaged or defective organs. Without much fanfare, miniature implantable pumps are ushering in a new era of...

Chile: A Trailblazer in South America

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column BOTTOM LINE With a strong economy and the backing of its president, Chile's expanding emphasis on health care signals an increasingly strong export market for U.S. medical...

Where to Go for EtO Info

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column HELP DESK When facing the task of sterilizing their devices, manufacturers need to understand the types of sterilization processes available as well as the effects such...

Accelerating the Product Development Cycle

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column PRODUCT DEVELOPMENT Familiarity with techniques that speed up the design process can help manufacturers increase profit margins by beating the competition to market and...

CE Marking via Self-Declaration

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI September 1997 Column EUROPEAN REGULATION Understanding CE regulations poses a challenge even to Class I manufacturers. Most U.S. manufacturers are now aware that after June 13, l998, all...