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.

Previous knowledge of ISO 9001 is a pre-requisite for this course. If you need to improve your knowledge of ISO 9001, we recommend taking our ISO 9001:2015 Requirements course.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Anyone involved with the implementation of the ISO 13485:2016 standard 

Learning objectives

  • 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

Course Benefits

  • 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

Next Steps

  • Lead Auditor: ISO 13485:2016 - Review ISO 13485:2016 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.

Express your interest

Contact our training experts and we will discuss your needs with you.

Request an in-house training quote

Contact Us

Contact our training experts on
0800 583 965