ISO 13485:2016 sets out the requirements for a quality management system specific to the medical device sector. Medical devices include all products intended for diagnostic, prevention and treatment purposes. Some are relatively simple, such as dressings, while others are more sophisticated, such as dental chairs, cardiac pacemakers, vital function maintenance and in vitro diagnostic reagents.

The standard has an extended scope for all bodies involved in the life cycle of the product - from design to end-of-life - a regulatory harmonization alignment and a greater focus on post-marketing surveillance, including handling complaints.

Particular importance is given to having adequate infrastructure, particularly for manufacturing sterile medical products, as well as risk management.

The standard allows organizations to demonstrate compliance with regulatory requirements and will help those involved in the development, distribution and maintenance of medical devices to improve their processes, better manage the risks and improve the quality of their products.