Achieving ISO 13485 Certification in Medical Device Manufacturing

The medical device industry is familiar with ISO 13485 certification, which is a requirement for exporting products to the European Union. Today, we will systematically share the relevant content of ISO 13485

First, what is the ISO 13485 standard? The ISO 13485 standard is a quality management system standard applicable to the medical device regulatory environment, with the full name “Medical devices – Quality management systems – Requirements for regulatory purposes”. It adopts the PDCA concept based on the ISO 9001 standard. Compared to the ISO 9001 standard which is applicable to all types of organizations, ISO 13485 is more specialized, focusing on organizations in the medical device design, development, production, storage and distribution, installation, service, and final decommissioning and disposal industries. Organizations can establish systems or seek certification based on the ISO 13485:2016 edition standard.

Second, what are the key contents of the ISO 13485:2016 standard? The standard emphasizes the organization’s responsibility to meet regulatory requirements; focuses on risk-based management processes; highlights the requirements for communication and reporting with regulatory authorities; and places greater emphasis on document and record requirements compared to ISO 9001.

Finally, what types of organizations are applicable? ISO 13485 certification mainly involves organizations such as medical device designers and manufacturers, medical device operators, medical device service providers, medical device software and hardware developers, and medical device component/material suppliers.