ISO 13485 Quality Management System for Medical Devices

WHAT IS ISO 13485?

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Originally developed in the 1990s, the standard details requirements for a quality management system that meets both customer requirements and regulations in the European Union (EU), Canada and other major jurisdictions around the world. ISO 13485 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.

WHAT ARE THE BENEFITS OF AN ISO 13485 CERTIFICATION?

• Organisations certified to ISO 13485 demonstrate their commitment to continuous & systematic process improvement
• The certificate can significantly improve your bargaining position when taking part in public and private procurement tenders related to Medical Devices
• To support you in strengthening your quality management systems and processes for medical devices

TÜV SÜD IS YOUR PARTNER FOR COMPLETE Quality MANAGEMENT SYSTEM COMPLIANCE for medical devices

• TÜV SÜD is ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification
• TÜV SÜD Product Service is the largest EU Notified Body in the world, and our technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices
• TÜV SÜD offers a complete range of testing, certification and auditing services to manufacturers of medical devices, helping them to manage risks and to protect and promote the health and safety of patients, users and, where appropriate, other persons

Fill-in the adjacent form to download the ISO 13485 Infosheet and learn about the ISO 13485 certification process from TÜV SÜD:

Download the ISO 13485 Infosheet