This course extends your knowledge of the various international health regulations concerning medical devices, as well as the legal requirements applicable to companies in the sector. You will also develop the skills you need to support the implementation of national regulations within the QMS of these organizations.
This knowledge, and the application of the legal and regulatory requirements, will underpin a successful ISO 13485 implementation in organizations that manufacture, import, store, and/or condition and perform maintenance upon medical devices. The course is most relevant if you are responsible for regulatory affairs, quality control, design and development, maintenance or quality management systems.
Find out more about our ISO 13485 - Interpretation Training - Quality Management Systems for Medical Devices by contacting SGS today.