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February 2007
Medical Device & Diagnostic Industry
Selected Contents












From the Editors

GE Consent Decree: Not Your Problem? Don't Be Too Sure

Sherrie Conroy

With the high-profile consent decree that GE Healthcare signed recently, FDA may be telling industry to pay more attention to CAPA.

Cover Story

Movers and Shakers of 2006

MD&DI examines the events and people that influenced the state of the industry in 2006 and provides perspective on the future of medical devices.

Machining

Laser-Micromachined Marks Track Small Surgical Implants

Sri Venkat and Kevin Simmons

Laser-made identifiers on devices help to track products and protect them from counterfeiting.

Sidebar:
Why Mark Devices and Implants?

Design Strategies

Medical Device Design: Learning from the Consumer Industry

David Robson

Device makers can use design ideas from the consumer industry and still meet regulatory standards.

Washington Wrap-Up

FDA Rewards Many Figures in Utah Medical Case

James G. Dickinson

Although the agency lost the case against Utah Medical, it has awarded bonuses to many employees who were involved. What message is FDA sending?

Product Development Insight

Seven Steps to a Systematic Literature Review

Barb Danson

A formal literature review is critical to building quality into medical device development.

Regulatory Outlook

Freedom of Information Act Requests: A Primer

Marlene Bobka and Nancy Singer

Device makers should know how to get meaningful data from Freedom of Information Act requests.

Sidebar:
Effectively Using an FOIA Log

Industry News

R&D Digest