ISO 13485:2016 Deep Dive - Clause by Clause

To address the requirements of Medical Device Directives, 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.


Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
This training course is HRDF approved under the SBL scheme. On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

What will I learn?

On completion, you should gain the knowledge and skills to:
  • 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

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

Learning method

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you get the skills to apply your knowledge straight away. This course involves practical activities as well as toolkits, templates and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance. 
Register for Public Training Get quotation for in-house training

    o    Suitable for small groups
    o    Suitable for single person
    o    Learn from other organizations
    o    HRDF Claimable

    o    Suitable for large groups
    o    Flexible & convenient
    o    Tailored for your needs
    o    25% - 30% cheaper
    o    HRDF Claimable


Available as an In-House Course Only

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Course Guides & Materials

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