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October 2008

Downloads

Download a sample of the 2008 International Compliance Code Compendium

Expanded Online Articles

Developing an In-House Reimbursement Paradigm

Effective reimbursement strategies start with open communication channels in-house.

Q&A: Preaching the Value of Human Factors

For more than 30 years, Peter Carstensen was CDRH's chief authority on human factors engineering. He's now bringing his expertise to the private sector.

Regulatory Outlook: Identifying the Right Notified Body for Entering the European Market (includes expanded table)

Device manufacturers need to consider many factors when choosing a notified body. Finding the right one can increase chances for successful market entry.

Video

See a Video Demonstration of Vibration Testing

(Read the NewsTrends Article: Proper Product Testing Avoids Bad Vibrations)


August 2008

Q&A

The Case for Evidence-Based Compliance

Erik Swain

The government now expects companies to show that the policies to stop inappropriate payments and perks to physicians are working. Michael Bell is helping enable firms to do that.

Guide to Outsourcing

Five Considerations for Opening an Offshore Facility

Roger Brink

Lessons learned during the hunt for the perfect manufacturing location.

Video

Sample Instructional Animation Videos

Animated Demonstrations of Magnetic Field Technique

Expanded Online Articles

UV Micromachining: Shorter Pulses or Shorter Wavelength?

For many medical devices, cost-effective state-of-the-art micromachining can be obtained by using a laser with short output pulses and high beam quality.

Animated Videos Guide User Interactions with Complex Medical Devices

For many medical devices, cost-effective state-of-the-art micromachining can be obtained by using a laser with short output pulses and high beam quality.

The Greening of Medical Product Design

How to make medical device products more sustainable.

12 Key Questions for Selecting a Supplier

Answering these questions will help a company zero in on the right supplier.

Automated Testing for Real-Time Embedded Medical Systems

Medical device companies, especially those with real-time embedded-system products, are often burdened with lengthy verification cycles.


July 2008

Cardio Technology Trends Video

Diagnosing Heart Disease Through PET·CT Scans

Revolutionizing Heart Care

Expanded Online Article

Microwire Use in Catheter-Based Medical Device Applications, Part 2

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


May 2008

Testing

Segmental Compression Benchtop Testing Video

See bonus footage of a segmental compression system measuring and recording the radial stiffness and strength of a self-expanding stent.


April 2008

MDEA 2008

Medical Design Excellence Award Winner Videos

For the first time ever, MD&DI has posted videos of Medical Design Excellence Award winners. These are the same videos entrants supply to MDEA jurors.


March 2008

Guide to Outsourcing

What Your Mother Never Told You About Outsourcing to China

Rick Rogers and Gray McCord

Thinking about moving your manufacturing to China? It's not an easy process, so be sure it's the right decision.


February 2008

Web Site Directory

Need a quick reference point for your favorite manufacturers’ Web sites? Look no further.

Regulatory Outlook Expanded Version

Revised EU Directives: Many Changes in Store

Roger Gray

A directive revising European medical device regulations is scheduled to take effect in March 2010.


January 2008

A Comprehensive Guide to the Quality System Regulation Preamble

Kristin Miller and William A. Hyman

Q&A Expanded Version

Global Harmonization Is Here to Stay

Erik Swain

Larry Kessler, chair of the Global Harmonization Task Force, has seen his organization make great strides, but some obstacles remain.