ISO 13485 Training that offers a more convenient, flexible and effective way to learn about Quality Management Systems for Regulatory Purposes.
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 product, including quality management system-related services to such organizations.
2023
Catalog
This course is for anyone that wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021-1.
Blended
CQI & IRCA Exemplar Global This course is for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.
eLearning
Exemplar Global This course is for anyone who needs to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).
eLearning
CQI & IRCA Exemplar Global This course is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).
eLearning
CQI & IRCA Exemplar Global 
