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July 2008
Medical Device & Diagnostic Industry
Selected Contents





From the Editors

Be Prepared: Software Forensics Gaining Steam at FDA

Sherrie Conroy

Although the jury is still out on static analysis tools, software forensics is gaining steam.

Cardio Technologies

The Heart of the Matter

Sherrie Conroy

The cardio sector has benefitted from a host of advances that keep a pulse on patient needs.

Sidebar:
The Revolutionary Role of Imaging | Prevention: The First Step

Precision Technology

Simulation: Ways to Optimize Production

Joseph Fox, Santiago Archila, and Martin Baumann

Manufacturers can use simulation tools to comply with regulations and improve production processes.

Molding

Device Creation with Thin-Wall Molding

Clare Frissora and Greg Tremblay

Designers must keep material, machinery, and mold in mind.

Catheter Design - Expanded Online Version

Wired for Catheter Applications, Part 2

Brett Steen

Incorporating microwires into catheter design offers new opportunities for sensor applications.

Washington Wrap-Up

Will FDA Become $275 Million Richer?

James G. Dickinson

If Congress approves, FDA will have more money to carry out its mission.

Regulatory Outlook

Tips on Submitting Preclinical Data to ODE

Elisa Harvey, Semih Oktay, Daniel Chwirut, and Judy Danielson

A little forethought can help device companies avoid errors when submitting preclinical data to ODE.

Sidebar:
Avoiding Submission Errors | Top 10 Errors in Preclinical Testing Submissions