Introduction to ISO 13485 Medical Devices

ISO 13485 shapes quality management systems for medical device manufacturers the world over. The international standard shows customers and competitors that you take quality seriously. Sign up for our Introduction to ISO 13485 Medical Devices Training Course and don’t get left behind.

ISO 13485 applies to design, development, production, installation and servicing of medical devices. And compliance is a measure of your ability to meet customer and legal requirements.

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On this one day course we will explain how ISO 13485 is implemented and draw links with other quality standards. You will review and compare ISO 13485 requirements with ISO 19001:2008 and the Food and Drug Administration (FDA) Quality System Regulation and you will begin to understand the relationship between ISO 13485 and ISO 14971:2007 (Application of Risk Management to Medical Devices).

Learning objectives

• Understand the importance of ISO 13485 on an international scale
• Differentiate between ISO 13485 and ISO 9001
• Get to grips with the different elements of ISO 13485 and ISO 14969:2005
• Understand the relationship between ISO 13485 and ISO 14971 
• Define ISO 13485 management roles and responsibilities
• Compare requirements between ISO 13485 and the FDA’s Quality System Regulation.

Benefits of attending this course?

• Take the first steps towards ISO 13485 accreditation
• Understand how you can better meet customer and regulatory requirements
• Find ways to increase efficiency and cost savings through quality management
• Monitor supply chains to achieve continuous improvement
• Develop safe and effective medical devices
• Motivate employees through CPD.