Project Description


You need this course if you want to know how to design and implement an effective QMS based on ISO 13485:2016, prepare for ISO 13485 certification or you want to improve the effectiveness of your current system.

You will learn how to implement a QMS based on ISO 13485:2016 and the importance and relevance of legislation surrounding medical devices.


As well gathering knowledge surrounding documenting systems, processes and typical methods, this course covers core topics such as:

  • how to develop a quality policy and objectives
  • how to implement processes for improving the effectiveness of the system
  • how develop an appropriate management review process
  • how to plan and manage your internal quality auditing activities
  • how to eliminate the causes of problems through effective corrective action

And… you will also have the opportunity to understand a few hot topics such as:

  • the significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
  • the requirements surrounding software validation
  • understand the key features of risk assessment as defined in ISO 13485
  • the design and development requirements in ISO 13485

The course duration will be 2 days and encompasses a class room style, relevant and engaging exercises supported by comprehensive notes.

Book a Training Course for your Medical Device Regulation

For pricing please send us an enquiry by completing the form and we will get in touch with a quotation