ISO 13485 Training Courses on Medical Device Quality Management Systems (MD-QMS)

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

Comply Guru offer the following types of ISO 13485 training courses depending on the target audience and/or learning objectives, including:

1. Essentials Training is for those who only need a short, high-level overview (awareness) of the basics of ISO 13485. This course is available via eLearning.
2. Foundation Training is for those who need to gain a comprehensive understanding of the ISO 13485 requirements. This training is recommended for everyone who might be completing Internal or Lead Auditor training. This course is available via eLearning.
3. Internal Auditor Training is for those who need to be able to conduct ISO 13485 internal audits of part of a Quality Management System (QMS) as part of a team. This course is available as Blended or Instructor-led Learning.
4. Lead Auditor Training is for those who will be tasked with conducting full system 1st party (internal audits), 2nd party (supplier audits) or 3rd party ISO 13485 audits (external or certification audits). This course is available as Blended or Instructor-led Learning.