ISO 13485:2016 Introduction Training course

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.

Delegates gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

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.

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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.

Delegates will be able to:

  • explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • identify the relationship between ISO 13485:2016 and European Medical Device Directives
  • recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

ISO 13485:2016 learning path and combination discount

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

Stappenplan Engels

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

1. ISO 13485 Introduction - € 690,-

2. ISO 13485 Implementation - € 1.375,-

3. ISO 13485 Internal Auditor - € 1.375,-

4. ISO 13485 Lead Auditor - € 3.250,-

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

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

In-house training course
Training courses can be delivered at your location. Based on your learning needs we could provide a customized in-house training course for your team.  

For more information about the learning path or In-house training courses, please contact our training team via +31 20 346 07 80 or send an email to

Practical information

  • It's a 1-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included

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