You are invited to the joint meeting of IEEE Boston Section EMC Chapter and New England Product Safety Society will be held on Wednesday, September 24, 7:00 PM, at EMC Corporation, 42 South Street, Hopkinton, Massachusetts. Training by recognized expert in addition to refreshments will be offered. You can not lose by attending this informative meeting.
Electromedical Device EMC, Product Safety and the FDA GMP by Wayne HUNTER, GE Medical Systems, Milwaukee, Wisconsin This presentation will provide information about EMC requirements for electromedical device manufacturers. EMC is now required for Electromedical devices under section 820.30 of the FDA Good Manufacturing Practices (GMP). GMP will require all electromedical manufacturers to provide information in regard to intended EMC environment as well as verification data for new products. The impact of the new FDA GMP on product safety will be reviewed. The new GMP went into effect on June 1, 1997. This requirement directly affected finished device electromedical device manufacturers and indirectly sub-contractors of electromedical device manufacturers. Additional information will be presented in regard to FDA design controls included in the Code of Federal Regulations. What changes will be required if you are currently CE marking your product? Will other countries harmonize with the CE mark requirements? What is the current status and timetable for the MRA with Europe? Discussion of the answers to these and other questions will be included. Wayne Hunter is a member of the US National Committee EMC Technical Advisory Groups for CISPR, IEC, NEMA, ANSI, and the IEEE. If you need more information, contact Mirko Matejic at (508) 549-3185, email: mmate...@foxboro.com. More information about meeting is available at URL: http://www.ece.neu.edu/ieeebost/articles/articles.html
