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

Online training

Do you prefer the convenience of an online training course? BSI offers training courses online via Connected Learning Live. 

Read more about Connected Learning Live

Practical information

  • It's a 2-day training.
  • The training and the materials will be provided in English.
  • Lunch and drinks are included for the classroom training

For further information regarding reduced rates at the hotel where the training is being conducted please contact or 0031-(0)20-3460780.