ISO 13485

ISO 13485 Medical Devices Quality Management Systems

This International Standard specifies requirements for a Quality Management System where an organization for needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to Medical Devices and related services.

The primary objective of this standard is to facilitate harmonized Medical Device regulatory requirements for Quality Management Systems.

ISO 13485 Certificate

Cookies are used on this site

Use of cookies