ISO 13485 Foundation: medical device quality management

ISO 13485 is an international standard for the medical device industry. It was created to help companies address the medical device lifecycle, from production to post-production, including decommissioning and disposal. However, this quality standard also applies to other stakeholders, including certification bodies contributing to approval procedures. ISO 13485 provides management professionals with a tool to develop and maintain their processes effectively.

This course provides the basic knowledge required to implement and manage a medical device quality management system (MDQMS) in accordance with ISO 13485 requirements. Over 2 days, you will explore the components of an MDQMS, such as policies, procedures, performance measures, management commitment, internal audit, management review and continual improvement of the management system.
 
At the end of the course, you will take the official PECB exam and may earn the PECB Certificate Holder in ISO 13485 Foundation credential. This certificate demonstrates your understanding of the fundamental methodologies, requirements, framework and management approach.