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ISO 13485
Medical Devices - QMS

ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Who should attend this training courses?

  1. Managers, Head of department, medical device quality professionals with knowledge of quality management systems and ISO 13485:2016

  2. Member of ISO 13485:2016 system, consultants

  3. Individuals who want to become internal auditors, ISO 13485:2016 lead auditors


What courses will you be training in?



Certified Lead auditor Training

Expand your auditor's knowledge, practical awareness and expertise with an internationally recognized certification.


Awareness and Internal Auditors Training

The ISO 13485:2016 training course helps students understand the terms, requirements. Along with optimizing your skills and enhancing your internal audit capabilities.

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System building training

Building and applying ISO 13485:2016 helps to understand how to implement a QMS as required by medical device directives, identify the purpose, benefits and take the steps towards ISO 13485:2016 certification

How will I benefit?

  1. Get in-depth knowledge of the requirements of ISO 13485:2016

  2. Develop confidence to apply this knowledge in your organization

  3. Can perform project analysis and planning


What will the training include?

  1. Detailed course material

  2. Tea-break

  3. Won-Med Certification Body Training Academy Certificate, an internationally recognized lead auditor training course


Why choose training from Won-Med?

  1. Won-Med with a team of lecturers who are leading experts in your field, we train in-depth courses on ISO international management systems, CE/FDA certification, Lead Auditor. The courses are designed in a tailor-made style to suit each industry and each type of business. With a team of lecturers who are truly passionate about sharing their knowledge and making sure you can capture the most solid knowledge to apply to your own work.

Best support for you, please contact:


Hotline: +84 978 719 518– Email:

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