The regulations for medical technology and in vitro diagnostics, place demands on the quality of management systems. During this webinar, you will receive an overview of concepts such as quality management systems and the purpose of this, and an introduction to the ISO 13485 standard.

Course description:

The regulations for medical technology and in vitro diagnostics place demands on the quality of management systems. A common and well-known standard for quality is ISO 9001, but for medical technology reference is made to ISO 13485, which is also a process standard similar to ISO 9001, but the requirements are intended to comply with the MDR and IVDR regulations. It is necessary for all manufacturers of medical devices to be able to show that they meet the requirements of the quality management system in accordance with the regulations. This is regardless of how great the risks may be with products (regardless of class). ISO 13485 is a good tool to achieve this.

During this webinar, you will receive an overview of concepts such as quality management systems, the purpose of these, and an introduction to the ISO 13485 standard.