ISO 13485

ISO 13485:2016 for medical devices


The course is aimed at those who work in a medical device or in vitro diagnostic company and want to train in ISO 13485:2016.

ISO 13485 is designed to be used by companies and organizations involved in the design, production, installation and servicing of medical devices and services. Internal and external parties, such as certification bodies, can use ISO standards to support their auditing processes.

This course gives you an overview of ISO 13485:2016. The responsibilities of management and staff in a medical device company and the recommended processes and responsibilities. Changes from the previous edition of ISO 13485 and the link to MDR. After the training, you should have gained knowledge of the standard and the changes in the 2016 version. You also have good knowledge to be able to implement business processes that are adapted to ISO 13485:2016.