February 2005
Medical Device & Diagnostic Industry
Selected Contents
Editor's
Page:
The Emerging Age of Biologics and Devices
Cover Story
Making the Right Call on Contract Machining
William Leventon
A number of factors can help you decide whether or not to outsource machining work.
Corporate Newsmakers
Making News in 2004
Roundtable
Medical Device Design: Developing a Winning Strategy
Design experts discuss the essential elements of setting a design strategy that results in the development of successful products.
WASHINGTON WRAP-UP
White House, HHS, and FDA Changes Bring Uncertainties
James G. Dickinson
Rumors about who will be nominated to head FDA raise questions about the future of many agency programs.
NEWSTRENDS
- RFID Tag May Improve Patient Safety
- Despite Complaints, FDA Shows Progress on SUD Reprocessing
- As Modular PMAs Grow More Complex, Industry Faces Choice
- Want a Quick PMA Process? Be Ready for Inspection
R&D DIGEST:
- Diamond-Coated Catheters Are Forever
- Nanotube Coatings Strengthen Implants
- Eel Vertebrae Could Hold the Key to Neuroprosthetics
Product Development
Insight
Design for R&R: A Product Quality Methodology
Scott Heneveld,
Arrows Design
Design engineers need a quality system that enables them to develop a systematic development process to meet increasing product requirements.
Sidebar:
Multiple Mechanisms
Regulatory Outlook
IEC 60601-1, 2005: A Revolutionary Standard, Part 1
Mike W. Schmidt,
Strategic Device Compliance Services
The third edition of the standard is a more-comprehensive, better-organized document. But will you be prepared for all the changes?
