Quality Management System for Medical Devices
ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system that an organization must demonstrate its ability to deliver medical devices and related services consistently meet the customer's requirements and applicable regulatory requirements. It is intended for use by organizations for the design, development, manufacture, installation, maintenance and sale of medical devices.
The main purpose of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is an independent standard. It is generally based on the structure of ISO 9001, but includes some specific requirements for medical devices such as risk analysis, sterile production and traceability. Organizations certified according to ISO 13485 cannot request compliance with ISO 9001.
Who is ISO 13485 applicable to?
ISO 13485; It contains vital demands that are applicable to all organizations involved in or affiliated with medical devices and the pharmaceutical supply chain. These are the manufacturers who want to demonstrate compliance with the demands of the applicable legal regulations, services that support medical device manufacturers, and all organizations related to this issue.
What are the Benefits of ISO 13485?
- It enables your company to increase its competitiveness in the international market and in the domestic market.
- Ensuring global compliance of devices with quality rules
- Increasing the production, design and service quality of devices
- Providing advantage in exports to European Union countries abroad
- Increasing trust in devices Protection of human health due to the increase in the quality of devices
- Facilitating compliance with relevant laws and regulations
