ISO 13485:2016 Consulting

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The required processes that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Some of the key aspects of ISO 13485 include:

We specialize in implementation assistance along with in-house or public training workshops.

The following ISO 13485 workshops are now available:

Request a project definition meeting

"*" indicates required fields

Address*
This field is for validation purposes and should be left unchanged.
0
    Your Cart
    Your cart is emptyReturn to Shop
    Reap the benefits

    Login with your Membership Credentials

    Not Yet a Member? Request Membership Now



    Introducing our Updated Website Designed to Enhance your Experience

    Explore our revamped website and experience a more user-friendly interface designed to serve you better!

    Thank you for visiting QSG!

    If you have any questions, would like more information, or would like to speak with a QSG representative, please contact us at any time!

    Interested in this course for the Future?

    Thanks for letting us know!
    Please fill in the information below so that we can keep you informed.
    Name
    I'm not registering yet because