Understanding ISO 13485
For medical device manufacturers that are active in the world market, implementing industry specific international quality standards is not only advantageous, it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or its equivalent. In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards.
This one-day seminar provides information and guidance to medical device organizations pertaining to changes in quality management systems necessary to comply with the U.S. Quality System Regulation, the ISO 9001:2000 generic quality system standard, and the ISO 13485 quality system standard for medical devices.
Who Should Attend:
Program Duration: One-day program, 9:00 a.m. to 6:00 p.m. $495
Locations: Atlanta, GA and at your location
Call us to get started: 1-800-355-3876
Phone: 770-395-0124 or 800-355-3876 Fax: 770-395-0737