It is an international standard that establishes the requirements for a quality management system (QMS) specific to medical devices. This standard is designed to ensure that organizations in the medical device sector can demonstrate their ability to consistently provide devices and related services that meet customer requirements and applicable regulations.

The main objectives of ISO 13485:2016 include:

1. Patient safety: Ensuring that medical devices are safe for their intended use.

2. Regulatory compliance: Ensuring that manufacturing processes meet international regulations.

3. Consistent quality: Maintaining a high level of quality throughout all phases of the product lifecycle, from design to distribution, including disposal.

This standard is based on the Plan-Do-Check-Act (PDCA) cycle process model and includes specific requirements for QMS documentation. It is particularly relevant for manufacturers, designers, and distributors of medical devices, helping them ensure that their products are safe and effective.