Medical Device & Diagnostic Industry

October 1998 MD&DI
Selected Contents

COVER STORY:
Can Inspection Time Be Reduced?: Developing a HACCP Plan
by Steve Maschino and William Duffell, Jr.

A medical device company details its experience as the first in the industry to participate in an FDA pilot program geared toward reducing the time of an inspection to as few as three days.

SQAE TRAINING:
Implementing Training Programs for Software Quality Assurance Engineers
by Tammy M. Pelnik and Gayla J. Suddarth

Given their potential to reduce software failures, well-trained SQAEs are essential for devices that rely on software.

RISK MANAGEMENT:
Integrating Risk Management with Design Control
by Peter L. Knepell

Making a risk management program part of a company's design control procedures satisfies FDA and improves device safety.

ISO 10993:
A Practical Guide to ISO 10993-3: Genotoxicity
by Gina M. Johnson, Paul J. Upman, and Richard F. Wallin

The growing concern that medical devices can contribute to changes in DNA structure is addressed in the standard on genotoxicity.

FIRST PERSON:
Third-Party Reprocessing Conserving Health-Care Resources
Pamela J. Furman

An association officer, representing the legal and regulatory interests of third-party reprocessors of medical devices labeled for single use, explains the virtues of this practice.

WASHINGTON WRAP-UP:
Judge Permits Spread of Unapproved Uses Literature
by James G. Dickinson

• New Model for Device Reviews
  
• Baxter Cited for EtO Problems
  
• HIMA Applauds CLIA Shift to FDA
  
• Steris Cited for Adulterated Kits
  
• Four Firms Seek Device Exemptions

R&D HORIZONS:
Coating Science
by Gabriel Spera

In the past, device manufacturers wanted surfaces to be inert. Now, they want them to be more active.

BOTTOM LINE:
Taking Small Businesses Public
by Art Beroff and Andrew Koopman

Although the IPO is the best-known way to go public, there are other ways for a company to reach the same goal.

HELP DESK:
How to Handle Increased Production Volumes

Carrie Hartill, senior consultant of Excel Partnership, Inc. (Sandy Hook, CT), discusses some of the considerations for a small manufacturer ramping up for increased production.

EMI FIELD NOTES:
Using EMC Design Reviews to Protect against EMI
by Daryl Gerke and William Kimmel

Addressing EMC issues early in the design process ensures the availability of a wide array of options at various prices compared with the limited selection that remains if this task is neglected until the last minute.

SNAPSHOT:
Industrial designer opts for Lifesaving Devices
by Kassandra Kania

INSIDE MD&DI:
Quid Pro Quo: FDA Pilot Program Needs Industry Support
Jennifer M. Sakurai

EDITOR'S PAGE:
To Market, to Market: Being First Doesn't Always Mean Staying First
by John Katz

The most dominant market position can collapse without updated technology and sensitive customer service.