IVD Technology
Magazine
IVDT Article Index
Originally published September, 1997
Quality systems for IVDs
On October, 31, 1997, IVD Technology and the American Association for Clinical Chemistry (AACC) will be teaming up to present a special program for manufacturers on "In Vitro Diagnostics: FDA Quality Systems and the EU IVD Directive."
Topics covered during the one-day conference will include implementing design control for IVD manufacturing; documentary requirements for quality systems; FDA's new requirements for purchasing, installation, and servicing; Europe's forthcoming IVD Directive; and harmonization and global markets for IVDs.
Guest speakers will include Maurizio Suppo, MD, director of the European Diagnostic Manufacturers Association, and Kimber Richter, MD, deputy director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.
The program will take place on October 31 at the Oak Brook Marriott Hotel (Oak Brook, IL). For a complete program and registration information, contact AACC at 800/892-1400.
