With over one million certified companies over the world, the international quality management systems standard ISO 13485 is among the most commonly used today.
Since the first publication in 1993, several revisions have taken place aligning those standards to the evolution of the market needs. The latest edition of ISO 13485 standard for the medical device industry was officially published February 25th, 2016.
Manufacturers have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
Soka University of America
1 University Drive
Aliso Viejo, CA 92656
Objectives of the training
Understand the new concepts and definitions introduced by ISO 13485:2016
Comprehend the new regulatory requirements and purpose for ISO 13485:2016
Cross referencing between the old and new versions for a smooth transition