Introduction ISO 13485:2016 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.

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 training courses in all combinations. We recommend the following order:

Learning path

In addition to this introduction training, the following training courses are part of the ISO 13485 learning path:

2. Implementation ISO 13485:2016 - € 1.375,-

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

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

When you choose a combination of training courses, you benefit from a price advantage:

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 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
  • 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.