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Benefits to you

Quality management overview

The course includes the latest in the ISO 13485:2016 version and you learn how to effectively work with the relevant requirements.

Course materials & certificate

Each attendee receives hand-out slides and templates to use in their project. A course certificate confirming attendee has the requisite knowledge is issued at the end of the course to every attendee who fulfills the requirements.

Be active

We keep boredom out of our classrooms and instead give you what you deserve, interactive and engaging sessions. The course has a learning goal and every section is followed up to ensure effective learning. You will be awake.

Course program

Day 1 – Morning

  • Standards
  • Product approval process
  • Introduction to ISO 13485/li>
  • Introduction to risk
  • The Quality Management System
  • Audits and Compliance
  • Document and record control
  • Medical device files
  • Management responsibility

Day 1 – Afternoon

  • Resource management
  • Product realization -Design
  • Product realization -Purchasing
  • Product realization -Manufacturing
  • Product realization -Process validation
  • Traceability
  • Design changes
  • CAPA
  • Complaints

Would you prefer a course held on your premises?

We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.


Register for a course

If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.

Register for a course

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800