ISO 13485:2016 Clause by Clause

Duration 2 days

Available to book: Virtual classroom €1220 View dates and book now

This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.

How will I benefit?

Describe the requirements and structure of ISO 13485:2016
Interpret and apply requirements relevant to your organization
Appreciate how a QMS can be applied as a framework to produce safer medical devices
Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

Explain the scope and the structure of ISO 13485:2016

Describe the requirements of ISO 13485:2016

Explain how to interpret the requirements of the standard within your organization

Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization

Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016
- Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
- Organizations preparing to put ISO 13485:2016 in place
- Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
- Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
You will gain:
- 14 CPD points on completing the course
- Training course notes
- Lunch
- Refreshments.
Download course guide >

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch