ISO 13485:2016 Medical Devices: Clause by Clause

Level Understanding Duration 2 days

Available to book: Public classroom View dates and Book now

This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.

Training will be delivered either live and online or in-person in a classroom setting. You will learn how to explain the scope and structure of ISO 13485:2016 and interpret what’s required for your own organization. You will finish this stage of your learning journey with deeper knowledge and confidence and have a clear pathway for putting ISO 13485:2016 certification into place for any organization.

How will I benefit?

Full understanding of ISO 13485:2016 requirements
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices
Comprehensive training notes and 14 CPD points on completion

- Explain the scope and the structure of the ISO 13485
- Describe the requirements of ISO 13485
- Explain how to understand and interpret and apply the requirements of the standard within an organization
- Develop an understanding of how the requirements of ISO 13485 are established in an organization and maintained
- Consider the systems that are required to implement an ISO 13485 quality management system
- Discuss how to ensure that the requirements of the system are effectively implemented to allow the organizations quality system to be certified and/or maintain certification
- Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485 and need to have a greater understanding of the management system.
- Organizations preparing to put ISO 13485 in place
- Personnel who have joined an organization who have ISO 13485 and require in depth knowledge
- Delegates attending the Lead Auditor to ISO 13485 course who do not already have a good knowledge of the standard
You will gain:
- Training course notes
- Lunch
- Refreshments

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