ISO 13485 Medical Devices Quality Management System-Introduction

To gain the chance to enter local and oversea markets for medical devices and related  services, you need to ensure your quality management system meets ISO 13485 requirements.  ISO 13485 is applicable to any medical device organization, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). It can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.


ISO 13485 contains requirements for improvement, using feedback from sources such as complaint handling, post market surveillance, handling of nonconformities, corrective actions and preventive actions. To ensure that worthwhile and cost effective improvements are being achieved.


It is applicable to all types of organizations, whether public or private sector, regardless of the type, size and nature of the organization or geographical location. It is a basis for such organizations to demonstrate her ability to meet customer and applicable regulatory requirements.

N_ISO 13485 with tarde mark R_Co-01