ISO 13485:2016 Implementation

Get international recognition and business opportunities with our Implementing ISO 13485 training course.

Open up markets to your medical devices by meeting global quality standards as well as legal and customer requirements.

Discover step by step how to design, plan and put in place your own ISO 13485 medical devices quality management system – and make sure your devices meet quality expectations at every stage from design to development and production.

Learn how to maintain best practice and achieve ISO 13485 accreditation – winning market and customer confidence.


Who should attend?

  • Those responsible for designing and manufacturing medical devices
  • Senior management and quality assurance professionals
  • Internal, external and notified body auditors
  • Industry and public sector regulatory professionals
  • Product designers and operations managers

What will I learn?

  • Understand the requirements and scope of ISO 13485
  • How to meet ISO 13485 requirements and achieve accreditation
  • Design, plan and implement an ISO 13485 quality management system
  • How to increase efficiency and improve operational standards

Prerequisites

You will need basic knowledge or experience of the medical device industry. We recommend that you complete our Understanding ISO 13485 Medical Devices training before this course.

How will I benefit?

  • Ability to implement an ISO 13485 quality management system
  • Compliance with and certification to the ISO 13485 standard
  • Maintain quality standards and deliver continual improvements
  • Monitor performance across your organization and supply chain