August 2001
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
Software regulation for patient safety: Easing the Burdens of FDA and Industry
The challenge facing the agency and industry alike is to develop a standard that allows for timely premarket review while still adhering to risk-based review criteria.
Achieving Efficacy and Sterility in Flexible Packaging Whether the priority lies in the sterilization method or the barrier level, packaging requirements can be easily met with a wide variety of material options. WASHINGTON
WRAP-UP: MEDICAL
PLASTICS & BIOMATERIALS: Increased functionality, versatility, and ease of use are among the characteristics that the latest coatings can add to a medical product.
Blow molding machine designed for high output.
COVER STORY:
Karen Berger and Dhuanne Dodrill
Optimizing EtO Sterilization
Paul J. Sordellini, Frank R. Bonanni, and Gregory A. Fontana
The use of advanced monitoring technologies in four key aspects of EtO sterilization can yield substantial business and regulatory benefits.
Preparing for Successful Design Transfer
Terry Zenner
Planning ahead for design transfer and using it as a management tool results in a smoother, less costly transition from development to production.
R&D DIGEST
A monthly review of new technologies and medical device innovations
THIS MONTH: Exploring Innovative Treatment Options for Degenerative Disk Disease * New Analytical Technique Could Provide Tools for Assessing Parkinson's Disease Patients
FDA Performance Review Reveals Problems
James G. Dickinson
The CDRH director's year-end report admits to a marked slowdown in device review time.
New Coatings and Processes Add Value to Medical Devices
William Leventon
Film and sheet downstream system developed.
Polycarbonate screws endure high temperatures, and more!
