CEOSH ISO 14971:2019 Medical devices - Application Of Risk Management To Medical Devices ISO Foundation Course

This foundation programme provides a comprehensive introduction to ISO 14971:2019, covering the standard’s structure, key requirements, and underlying principles. It is designed for professionals seeking a thorough grounding in the standard before pursuing more advanced audit or implementation roles.

Participants are guided through the structure and content of ISO 14971:2019, with emphasis on understanding each clause and its practical implications. The programme also introduces the broader context of management system standards and how they support organisational improvement.

The course is designed to be accessible to professionals from any background, providing clear explanations and real-world illustrations that bring the standard’s requirements to life.

Upon completion, participants hold a CEOSH foundation certificate that confirms their understanding of ISO 14971:2019. This qualification provides a solid basis for progressing to internal auditor, lead auditor, or lead implementer programmes.