Why should you attend?
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
Who should attend?
- Managers or consultants involved in Medical Devices Quality Management
- Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
- Individuals responsible for maintaining conformance with MDQMS requirements
- MDQMS team members
Learning objectives
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
- Learn how to interpret the ISO 13485 requirements in the specific context of an organization
- Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
- Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices