Introduction to ISO 13485:2016

Our one-day Introduction to ISO 13485:2016 Medical Devices training course will help you discover the importance of ISO 13485:2016 and the links to the Medical Devices Directives. Find ways you can increase efficiency and cost savings through quality management, while understanding how you can better meet customer and regulatory requirements.

Our training experts have years of experience auditing business in the Medical Devices industry all over the world and will provide you with an overview of the purpose and requirements of ISO 13485:2016 and how to improve customer relationships, operations and corporate culture by the effective use of a Quality Management System. Additionally, you will review and compare ISO 13485:2016 requirements with ISO 9001:2015 and the Food and Drug Administration (FDA) Quality System Regulation.

This course is an introduction for anyone involved in the development, implementation and management of a QMS based on ISO 13485:2016. Upon completing the training, you will be able to interpret all clauses of ISO 13485:2016 and recognise the role of management in implementing and maintaining ISO 13485:2016.


Who should attend?

  • Senior management and those tasked with implementing ISO 13485
  • Quality managers and regulatory affairs managers
  • Internal and external auditors
  • Anyone involved with the implementation of the ISO 13485:2016 standard

This training course is HRDF approved under the SBL scheme.

What will I learn?

  • Understand the scope and use of ISO 13485:2016 as basis of Medical Device Regulations
  • Interpret the clauses of ISO 13485:2016 worldwide
  • Differentiate between ISO 13485:2016 and ISO 9001:2015
  • Define ISO 13485:2016 management roles and responsibilities
  • Compare requirements between ISO 13485:2016 and the FDA’s Quality System Regulation

How will I benefit?

  • Take the first steps towards ISO 13485:2016 certification
  • 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

What does the fee cover?

  • Training course notes
  • Lunch
  • Refreshments
  • Loan copy of the standard (to be returned after the course)
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