ISO 13485:2016

ISO 13485 INTRODUCTION Understand the main concepts of a Medical Devices Quality Management System (MDQMS) 

ISO 13485 FOUNDATION Acquire knowledge on the best industry practices on implementing an MDQMS based on ISO 13485 

ISO 13485 LEAD IMPLEMENTER Develop the skills necessary to support an organization in implementing, managing, and maintaining an MDQMS based on ISO 13485 

ISO 13485 LEAD AUDITOR Develop the necessary skills to perform an MDQMS audit by applying widely recognized audit principles, procedures, and techniques 

TRAINING PROGRAM

Course ID ISO0121 ISO 13485:2016

Course ID ISO0221 ISO 14155:2020

Course ID ISO0321 ISO 14971:2019 

Course ID ISO0421 ISO 10014:2021

ISO 13485:2016 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. 

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). 

ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. 

Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.