ISO 13485 – Quality Management System certification for medical devices

The main objective of the ISO 13485 certification process is to ensure that medical devices consistently meet customer needs and applicable regulatory requirements.

The ISO 13485:2016 standard specifies the requirements for a Quality Management System according to which a company demonstrates its ability to provide medical devices and related services that comply with the requirements of the applicable regulatory framework, legislation and customer requirements.

Benefits

• Enhances consumer confidence that the medical device complies with the requirements of international, European and national standards
• Ensures compliance with the requirements of the existing National and European Legislation concerning medical devices