Learn the requirements of ISO 13485:2016 and how to implement a Medical Device Quality Management System.

Learn the requirements of ISO 13485 and how to relate the requirements to your business management system. This ISO 13485 Executive Overview Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to use the system to ensure customer requirements are determined and consistently fulfilled over time.

This ISO 13485 Executive Overview Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management.

Because of our independence, you may bring your particular compliance, process and system concerns to class and the instructor will work to answer your questions as best as possible.