ISO 13485 : 2016 Medical Devices Quality Management System standard was created on the basis of the ISO 9001 standard, it is an international standard that includes special requirements for medical devices. When an organization requests certification from this standard in the production of medical devices and Medical Devices, this institution is not required to be a manufacturer.

In addition to fulfilling legal requirements, medical device manufacturers who want to gain competitive advantage must prove that they comply with the requirements of the quality management system.

The ISO 13485 standard is a standard compatible with the ISO 9001 standard, the main difference from the ISO 9001 standard is that the Customer Satisfaction element is not sought.

Other obvious differences;

• Observance of sectoral requirements as well as legal or regulations such as the Medical Device Directive or FDA,
• Regulation of working environments for product safety
• Product development and design stages
• Traceability for implant devices
• Documentation and process validation for sterile devices
• Corrective and preventive activities

However, it is the first step for a medical device or medical product to enter the European Union market. One of the prerequisites of the EEC Medical Device Regulation and the In Vitro Medical Devices Directive and the CE Marking Regulation is sought in the ISO 13485 Certificate together with these directives.

It is the latest version of ISO 13485: 2016 standard 13485. It is based on ISO 9001: 2015 risk and process approach model.

What are the Advantages of ISO 13485 Medical Devices?

• It demonstrates that it complies with current legal requirements.
• It is mandatory to use CE mark on Medical Devices.
• With ISO 13485, the organization expands its customer portfolio by documenting that it works in accordance with an internationally recognized standard.
• It provides advantage and prestige against its competitors with ISO 13485 Certificate.
• ISO 13485 Provides reduction in customer complaints.
• ISO 13485 Reduces product errors.
• ISO 13485 System increases the profitability of the organization.
• With the ISO 13485 Management System, the company gains export advantage.
• With ISO 13485, establishment activities can be systematically monitored by senior management,
• ISO 13485 Quality Management System for Medical Devices has the opportunity to detect and correct the defective aspects of the organization,