ISO 13485 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices.

The primary objective of the standard is to facilitate harmonized QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organizations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.

ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.