October 2002
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S PAGE
Are You Making a Product or a Process?
COVER STORY
Understanding the Process Approach of ISO 9000:2000
Curt Flemming
The newest version of the ISO quality standard shifts the focus from the product to the processes behind it.
Sidebar: ISO 9001:2000 VS. ISO 13485:200X—THE BASICS
ROUNDTABLE
How
Contract Manufacturing is Reshaping the Device Industry
By some estimates, the global market for outsourced medical devices is now $8 billion. Industry executives say that the trends favoring outsourcing are likely not only to continue, but to grow stronger in coming years.
Sidebar: Roundtable Panelists
INTERNATIONAL AFFAIRS
Device Regulation in Asia: An Update
Ames Gross and Caroline Tran
Sidebar: General Recommendations to Carry out Effective Informed Consent for Clinical Trials in Japan
STERILIZATION VALIDATION
Using Recovery Tests to Assess Bioburden Procedures
Trabue Bryans and Karen Alexander
Sidebar: Recovery Testing Terms
WASHINGTON
WRAP-UP
FDA's Statland Leaves Lasting Mark
James G. Dickinson
Departing ODE director Bernard Statland broke impasse over TMJ product approval, setting a new standard for risk-based labeling.
R&D DIGEST:
- Anesthesia System Makes Medical Treatment Less Stressful for Children
- "Smart Dust" Could Aid Drug Research
- National Labs Collaborate on MEMS Device to Treat Blindness
- Invention Connects Brain Functioning to Limb Control
- Artificial Liver Trials Show Progress
FIRST PERSON
The Auditors Are Coming: Are Senior Managers Ready?
Colin Aldersley
NEWS & ANALYSIS
