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.

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.


Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

Prerequisites
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course. 

By the end of this 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

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 training.nl@bsigroup.com or 0031-(0)20-3460783.

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:

Leerroute

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

ISO 13485:2016 Introduction

 €          675

 

2

ISO 13485:2016 Implementation

 €       1.325

 

3

ISO 13485:2016 Internal auditor 

 €       1.325

 

4

ISO 13485:2016 Lead auditor 

 €       3.150

 

 

Total

 €       6.475

 

 

 

 

 

 

 

Investment

Discount

 

 Combination training 1 + 2 

 €       1.850

 €         150

 

 Combination training 1 + 3

 €       1.850

 €         150

 

 Combination training 1 + 4

 €       3.825

 €         200

 

 Combination training 1 + 2 + 3

 €       3.025

 €         300

 

 Combination training 1 + 2 + 3 + 4 

 €       5.975

 €         500

When there are more employees who need to understand, implement or audit your management system, a training could be delivered at your location as well. Based on your learning needs we could deliver 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


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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