To address the requirements of Medical Device Regulations, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. Learn to apply your knowledge to the development of an ISO 13485:2016 compliant QMS and maintain the on-going certification of your organization.
Please note: The training is in English.
How will I benefit?
This course will help you:
- 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
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
What will I learn?
On completion, you should gain the knowledge and skills to:
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Explain the scope and the structure of ISO 13485:2016
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Describe the requirements of ISO 13485:2016
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Explain how to interpret the requirements of the standard within your organization
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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
What's included?
- Access to the platform where classes will be held
- Access to the platform where the materials are posted
- On successful completion of the training, participants will receive an internationally recognized certificate
