ISO 13485:2016 Medical Devices Foundation Course

• Individuals involved in Medical Devices Quality Management
• Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
• Individuals interested to pursue a career in Medical Devices Quality Management

The aim of this course is to provide participants with an understanding of the quality and management system approach considering regulatory requirements and the requirements of ISO 13485:2016.

• Understand the purpose and business benefits that can be achieved through the implementation of a Quality Management System
• Outline the structure and content of ISO 13485:2016 and some key differences from the ISO 9001 Quality Management System Standard
• Understand and interpret the requirements of ISO 13485:2016 and how the requirements assist the organisation in the operation of an effective Management System
• Lay a foundation of knowledge for quality management system implementation based on
  ISO 13485:2016.

Upon completion of this course, participants should be able to:

• Understand the purpose and benefits of a quality management system
• Have a greater understanding of the structure, content and the intent of ISO 13485
• Explain the specific quality management-related requirements of ISO 13485
• Be familiar with the terms and definitions used
• Have a greater understanding of the concepts that underpin the content of the standard including systems and consideration of regulatory requirements
• Describe how the requirements are linked together to enable the organisation to achieve improved quality performance to meet customer and regulatory requirements

Offering better value for money, they can be designed to closely match your specific requirements.

Our course leaders have extensive experience across a wide range of sectors including manufacturing, service and professional organisations including Local, National and International Government. This wide experience enables them to make the course more interesting by using their relevant examples and case studies during workshop discussions.

Their team of staff has extensive experience of working across cultural boundaries, through their work in Europe, Africa, Middle East, Asia and the Americas.

Delegates successfully completing the course will be awarded a certificate from SAI Global.