ISO 13485

ISO 13485 Quality Management System for Medical Devices

Efficient medical device quality management and testing

Efficient medical device quality management and testing

Certify your quality management system for medical devices with ISO 13485

Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system. Medical devices manufactured or supplied by organisations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.

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. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.

Why is it important?

In the EU, the requirements of EN ISO 13485 have been harmonised with the essential requirements of the EU’s Medical Device Regulation and In-Vitro Diagnostic Medical Device Regulation. Certification to EN ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives. In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485.

How can we help you?

TÜV SÜD is one of the largest organisations providing certification services under the EU MDR and IVDR, and our technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are one of leading global management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. Each audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system. This combined experience makes TÜV SÜD ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification.

Why choose TÜV SÜD

TÜV SÜD offers a complete range of testing, certification and auditing services to manufacturers of medical devices. Our global network of more than 750 dedicated medical health and services professionals include noted scientists and physicians in their respective fields. These capabilities make TÜV SÜD the preferred single source for worldwide compliance with medical device regulations.



in vitro diagnostic infographic

The In Vitro Diagnostic Medical Device Regulation

Following the publication of regulation (EU) 2022/112, the IVDR will be rolled out gradually.

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New Medical Device Regulation

The Medical Device Regulation

Understand the requirements of the MDR

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