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2000 The Presidential Election and the Medical device industry Mutual Recognition Agreement The Expert Witness Injunctions Warning Letter Review: Labeling Claims Do all design changes require Design Control? A legal look at the ISO 9000 Dealing with a "Difficult" FDA Investigator China: Workforce of the Future Has the FDA lost its Objective? 1999 1999- year end review Trip to the Orient - MD Factories The Next EU Hurdle - October, 1999 ISO 9000-2000 "Problems,September 1999 How To Respond to a 483 - August 1999 FDA Warning Letter Update - July 1999 Training? What is required? June, 1999 Y2K Demystified --- May, 1999 MDR's a pain in the --- April, 1999 Recalls and the FDA March 1999 Warning Letters or not? February 1999 Monica and the FDA - January 1999 1998 1998 The Year in Review - December 1998 #12 QSIT - November 1998 #11 IVDD the Next EU Hurddle - October 1998 #10 Confusion with CE mark - September 1998 #9 ISO vs GMP- August 1998 #8 HAACP Approach -July, 1998 #7 CE mark - June, 1998 #6 Design Review - May, 1998 #5 Corrective Actions - April, 1998 #4 FDA Affidavits and You - March, 1998 Issue #3 Ionic Contamination - February, 1998 Issue #2 You Should Be Aware - January, 1998 Issue #1
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