We are delighted to announce the release of a new course: 
Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSR. 

The holder of an authorisation to market a medicinal product may wish to change the terms of the authorisation – for example, to allow the holder to adjust the composition of the product, alter its manufacturing process, or enable it to be used in a different way. In the European Economic Area, such changes are called variations, and the marketing authorisation holder is required to submit to the relevant regulatory authorities a notification of the changes or an application for permission to make them.

Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). The internationally recognized standard specifying requirements that a medical device QMS should meet is ISO 13485:2016 from the International Organization for Standardization. The US Quality Management System Regulation (QMSR) incorporates this standard by reference, and compliance with it is enforced by the US Food and Drug Administration (FDA) from 2 February 2026.

This course lays out requirements of ISO 13485:2016 and the QMSR, setting them in the context of good manufacturing practices for medical devices.

For all the course information and to buy click here