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What is ISO 13485
TÜV SÜD audits and certifies the quality management systems (QMS) of medical devices according to the ISO 13485 standard. This standard addresses the development, implementation and maintenance of a QMS intended for use by medical device manufacturers and suppliers. Adherence to ISO 13485 assists with meeting market access requirements in several major jurisdictions around the world.
Why ISO 13485 is important
The quality of medical devices directly impacts their effectiveness and the safety of patients, users and other persons. For these reasons, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system.
In the EU, the requirements of EN ISO 13485 have been harmonised with the General Safety and Performance 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 General Safety and Performance requirements of these important regulations.
In the U.S., the Food and Drug Administration (FDA) have updated their requirements for Quality Management Systems to be closely aligned with ISO 13485 in January 2024. This revised part 820 is referred to as the Quality Management System Regulation (QMSR).
Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485 as a part of the Medical Devices Single Audit Program (MDSAP) program.
In Singapore, manufacturers, importers and wholesale suppliers of medical devices are required to comply with the updated SAC ISO 13485 accreditation program by 1 January 2025.
In South Africa, from 1 April 2025 on South African Health Products Regulatory Authority (SAHPRA) requires all medical device manufacturers and distributors to hold an ISO 13485 certification from a SAHPRA-recognized certification body.
In the EU, the requirements of EN ISO 13485 have been harmonised with the General Safety and Performance 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 General Safety and Performance requirements of these important regulations.
In the U.S., the Food and Drug Administration (FDA) have updated their requirements for Quality Management Systems to be closely aligned with ISO 13485 in January 2024. This revised part 820 is referred to as the Quality Management System Regulation (QMSR).
Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485 as a part of the Medical Devices Single Audit Program (MDSAP) program.
In Singapore, manufacturers, importers and wholesale suppliers of medical devices are required to comply with the updated SAC ISO 13485 accreditation program by 1 January 2025.
In South Africa, from 1 April 2025 on South African Health Products Regulatory Authority (SAHPRA) requires all medical device manufacturers and distributors to hold an ISO 13485 certification from a SAHPRA-recognized certification body.
How TÜV SÜD can assist you with ISO 13485
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.
TÜV SÜD is officially recognised by the (SAHPRA) as an approved body for issuing ISO 13485 certificates in South Africa. Additionally, we are also accredited by Singapore Accreditation Council in Singapore to facilitate the certification of companies to SAC ISO 13485.
In addition, we are one of the leading global management certification bodies for quality management systems, including management systems applicable in the manufacture of medical devices – (EN) ISO 13485. Each audit team consists of professionals with the skills and experience needed to accurately assess the compliance of your management system.
We offer a wide range of certification and auditing services to manufacturers of medical devices. Our global network of more than 1500 dedicated medical health and services professionals includes noted scientists and physicians in their respective fields.
TÜV SÜD is officially recognised by the (SAHPRA) as an approved body for issuing ISO 13485 certificates in South Africa. Additionally, we are also accredited by Singapore Accreditation Council in Singapore to facilitate the certification of companies to SAC ISO 13485.
In addition, we are one of the leading global management certification bodies for quality management systems, including management systems applicable in the manufacture of medical devices – (EN) ISO 13485. Each audit team consists of professionals with the skills and experience needed to accurately assess the compliance of your management system.
We offer a wide range of certification and auditing services to manufacturers of medical devices. Our global network of more than 1500 dedicated medical health and services professionals includes noted scientists and physicians in their respective fields.
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