TRANSITIONING TO ISO 13485

Abstract

The session will provide an overview of the new ISO 13485:2003 standard for the medical device industry. The course will include tips on practical ways to implement the standard, how to make the transition smoothly, and how to address new requirements such as customer feedback, process approach, and analysis of data.

Bio

Joseph Azary has more than 14 years experience in the Regulatory Affairs and Quality Assurance in the medical device industry.

Joseph has a bachelor's degree in biological sciences and a master's degree in business administration. He is an ASQ certified Quality Auditor, Regulatory Affairs Certified (RAC), and has completed and successfully met the testing requirements of the RAB certified lead assessor course for ISO 9001:2000.

U.S. Surgical Corporation, Johnson & Johnson, Fuji Photo Film (Fuji Medical division) are among Joseph's past employer's.

Additionally, Joseph has worked with over 55 companies assisting with projects ranging from ISO 13485 and 9001 certification, FDA compliance, quality system development, auditing, training, and 510(k) submissions.