Introduction to ISO 13485:2016 Medical Devices

This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485:2016 and ISO 14971, Application of Risk Management to Medical Devices.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the standard

By the end of the course delegates will be able to:

  • Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Understand the relationship between ISO 13485:2016 and European Medical Device Directives
  • Use ISO 13485:2016 as the basis of regulatory requirements worldwide.

 

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 training.nl@bsigroup.com or 0031-(0)20-3460780

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:

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Besides this introduction course, are the following training courses also part of the ISO 13485:2016 learning path:

2. Implementation

3. Internal Auditor

4. Lead Auditor

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

No.

Training

Price

 

1

 Introduction ISO 13485:2016

    € 675

 

2

 Implementation ISO 13485:2016

    € 1.350

 

3

 Internal Auditor ISO 13485:2016

    € 1.350

 

4

 Lead Auditor ISO 13485:2016

    € 3.200

 

 

 Total

    € 6.575

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 1.925

€ 100

 

 Combination training 1 + 3

€ 1.925

€ 100

 

 Combination training 1 + 4

€ 3.700

€ 175

 

 Combination training 1 + 2 + 3

€ 3.150

€ 225

 

 Combination training 1 + 2 + 3 + 4

€ 6.175

€ 400

If more employees need to understand, implement, audit, your management system, training 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 Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com.

In-company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to mark.leenaers@bsigroup.com.