ISO 13485:2016 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.

Demonstrate your ability to provide medical devices and related services that consistently meet quality and regulatory demands in line with ISO 13485:2016 Medical Device requirements for an effective Quality Management System (QMS).

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.


There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.

By the end of this course delegates will be able 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

Benefit from a combination discount

This course gets into more detail on the clauses of ISO 13485:2016 standard and can be seen as an important, additional preparation for the ISO 13485:2016 Lead Auditor training course.

The combination of these courses will ensure that delegates will gain full knowledge of the standard and contributes to the success in the position of Lead Auditor.

Therefore we offer a special discount to the delegates that apply for both training courses:





ISO 13485:2016 Clause by Clause + ISO 13485 Lead Auditor training course

€ 4275,-


€ 200,-

Practical Information

This two-day training course includes lunch and drinks. The training and the materials will be provided in English. For further information regarding reduced rates at the hotel where the training is being conducted please contact or 0031-(0)20-3460780.

Head + Heart + Hands: practical and effective learning

To retain your ability and enhance knowledge to effectively apply the skills our training concept Head, Heart and Hands becomes more and more important. Having a business perspective is essential from a performance point of view.

Headknowledge - know what is in the standard (background), acquire knowledge

Heart: attitude - why use the standard, what is the use of the standard for my organization, get motivated and continue to use the standard

Hands: behaviour - doing, practicing, making concrete and put into practice

Recognizable examples and assignments which can be made individually or in groups are used extensively in our courses. The course takes place on the basis of activities and has proven to have a positive effect on work performance while saving time and money because the first steps for the organization were already taken during the course.