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Introduction to ISO 13485.

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Introduction

This introductory course provides an overview of ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) for manufacturers of medical devices.

Who should attend?

  • Individuals, of any level, involved with an ISO 13485:2016 management system who needs an overview of the intent and requirements of the standard
  • Those involved with ISO 13485:2016 who need to create a single Quality Management System.

What will you learn?

  • Scope and application of the new standard
  • The differences between ISO 13485:2003 and ISO 13485:2016
  • Essential definitions and terminology
  • Key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
  • The relationship between the standard and the risk management standard ISO 14971.

What do you need to prepare?

No previous training or knowledge is required to attend this course.

What's included?

  • 7 CPD hours
  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

Course length

One day.

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