DSTU EN ISO 13485 / ISO 13485:2016
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes;
DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulation requirements (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT).
ISO 13485 sets requirements for a quality management system in which a company must demonstrate its ability to provide medical devices and related services that meet customer requirements and regulatory requirements for medical devices and related services.
The main purpose of ISO 13485 is to establish harmonized regulatory requirements for medical devices for quality management systems. As a result, it includes some specific requirements for medical devices. All requirements of ISO 13485 apply to different companies supplying medical devices, regardless of the type or size of the company. The processes required by ISO 13485, which are applicable to medical devices but not performed by the company, are the responsibility of the company and are taken into account in the company’s quality management system.