ISO 13485 Courses

Understanding ISO 13485

Introduction:  

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.

Program Content: 

• Background of the ISO 13485 standard and its current revision status.
• Understanding of the relationship of ISO 13485 to the ISO 9001 generic QMS standard and the U.S. Quality System Regulation.
• A section by section analysis of the relationship of clauses and the significant differences between ISO 13485:2003, ISO 13485:1996, ISO 9001:2000, and the Quality System Regulation.
• Implications of changes, how it will affect your company and the approach of Regulators to the proposed changes

Program Benefits:

• A thorough understanding of the requirements of ISO 13485 and the significant differences between it and related standards.
• A framework to take the necessary action to implement ISO 13485 and achieve registration.

Who Should Attend:

• Professionals involved in implementing, maintaining and auditing Quality Management Systems in a medical devices manufacturing environment .

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