(1) Background

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This is applicable to the organization involved in design and development, production, storage and distribution, installation, or servicing of a medical device and related services. ISO 13485 is aligned with European medical device directives; therefore, its implementation helps to fulfill the requirements of these directives such as CE marking. In order for marketing in the European country, the CE mark is mandatory to display on the device.

(2) Benefits of ISO 13485 Certification

• Harmonized standard for CE marking medical devices recognized by the European Commission.
• Improvement of credibility and image to have a system in place and show compliance.
• Improvement of customer satisfaction by assessing customer needs and expectations.
• Improvement in process to eliminate waste, reduce errors and avoid rework.
• Decision-making based on facts and data.
• Better employee engagement to increase efficiency and productivity.