ISO 13485:2016 Medical Devices Implementation

Level Implementation Duration 2 day

Available to book: Virtual classroom View dates and Book now

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

How will I benefit?

This course will help you:

Understand how to implement a QMS as required by medical device directives
Plan the implementation of ISO 13485:2016 within your organization
Take the first steps towards ISO 13485:2016 certification
Identify how you can better meet regulatory requirements
Find ways to increase efficiency and add value through quality management
Monitor supply chains to achieve continuous improvement

On completion, you should gain the knowledge and skills to:
- Define a quality management system
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization's current position with regard to ISO 13485:2016
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
- Training course notes
- Lunch and refreshments
- Certificate

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