Implementing ISO 13485:2016 Training Course

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Delegates develop knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.

Who should attend?

Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.


You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.

Delegates will be able to:

  • define a quality management system
  • identify the steps for defining, planning, organizing and scheduling necessary activities
  • implement an effective quality management system
  • conduct a base line review of an organization's current position with regard to ISO 13485:2016

ISO 13485:2016 learning path and combination discount

The ISO 13485:2016 Implementation learning path is modular. You can follow the training in all combinations. We recommend the following order:

Learning path

Besides this implementation course, the following training courses are also part of the ISO 13485 learning path: 

1. Introduction ISO 13485:2016 training course - € 690,-

2. Implementing ISO 13485:2016 training course - € 1.375,-

3. Internal Auditor ISO 13485:2016 training course - € 1.375,-

4. Lead Auditor ISO 13485:2016training course - € 3.250,-

Attending several training courses of a learning path is associated with special discounts.

Training courses Price Discount
Combination training courses 1 + 2  € 1.965 € 100
Combination training courses 1 + 3 € 1.965 € 100
Combination training courses 1 + 4 € 3.765 € 175
Combination training courses 1 + 2 + 3 € 3.215 € 225
Combination training courses 1 + 2 + 3 + 4 € 6.290 € 400

In-house training course
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to

Practical Information

  • It's a 2-day course.
  • The training and materials will be provided in English
  • Lunch and drinks are included
  • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.

For further information regarding reduced rates at the hotel where the training is being conducted please contact or 0031-(0)20-346 0780.