ISO 13485:2016 Introduction Training Course

11 januari 2022
(Hele dag)
Connected Learning Live (virtual),
BSI Group

ISO 13485:2016 is the international standard for quality for medical devices. In this introductory training you will learn to understand the aspects of medical device quality management and its importance for the future of your organization. You will learn how to apply the standard in practice for effective business operations. This training is an essential starting point when you or your organization will or want to work with ISO 13485:2016.

You could also follow this training course online via the interactive and virtual platform Connected Learning Live. Click on the button "inschrijven" and view the available dates and locations.

Who is the training for?

For anyone setting up, maintaining or monitoring the performance of the medical device quality management system. For example, senior management, quality managers, regulatory affairs managers and internal auditors.

No direct previous knowledge is required for the training. However, we do advise you to have read and, if possible, studied ISO 13485:2016 prior to the training.

What did you learn afterwards?

  • Can you interpret the ISO 13485:2016 standard requirements using ISO 14969?
    Have you gained insight into the differences between ISO 13485 and ISO 9001?
    Do you know the roles and responsibilities of management according to ISO 13485:2016?
    Can you recognize the relationship between ISO 13485 and ISO 14971?
    Can you compare the requirements between ISO 13485 and FDA's Quality System Regulation?
    Do you know the usefulness of ISO 13485:2016 which serves as the basis for the Medical Device rules worldwide?

Practical information

  • The training takes 1 day
    The training will be given in Dutch
    The training material is in English
    Including coffee/tea facilities and lunch
    Would you like to spend the night in the hotel before or during the training? We can reserve a hotel room for you at a reduced rate. If you would like to make use of this possibility, please contact us via training [dot] nl [at] bsigroup [dot] com.

    ISO 13485:2016 course
    The ISO 13485:2016 quality management course for medical devices has a modular structure. This means that you can follow the training courses in all combinations. If you wish to follow more than one training course, we advise you to follow the order below.

    In addition to this introductory training, the following training courses are part of the ISO 13485 course:

    2. Implementation ISO 13485:2016

    3. Internal Auditor ISO 13485:2016

    4. Lead Auditor ISO 13485:2016

    The price of this training is € 675,-

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

    ISO 13485 training



    Introduction + Implementation



    Introduction + Internal auditor



    Introduction + Lead Auditor



    Introduction + Implementation + Internal auditor



    Introduction + Implementation + Internal Auditor + Lead Auditor



11/01/2022 (Hele dag)
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