ISO 13485 : 2016 Awareness Training
Training Topic
ISO 13485:2016 Awareness
Duration
1 Day
Course Overview
Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Topics Covered
- The scope and application of the ISO 13485:2016 standard
- The differences between ISO 13485:2003 and ISO 13485:2016
- MedAccred Accreditation Process
- Essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
- The key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
- The relationship between ISO 13485:2016 and the risk management standard ISO 14971.
Whom To Attend
- Individuals interested in Medical Devices Quality Management
- Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management System (MDQMS)
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants
- Anyone involved with the implementation of the standard
Learning Objectives
- Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Understand the concepts, approaches, methods and techniques used to implement a Medical Devices Quality Management System (MDQMS)
- Understand the basic elements of a Medical Devices Quality Management System (MDQMS)
Certificate
Upon completion of the course you will receive an SafeWorthy ISO 13485participant Certificate.
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