Make a step to market entry for your medical devices in many global markets.
Make a step to market entry for your medical devices in many global markets.
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 which is 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.
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 harmonized 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.
TÜV SÜD is officially recognized 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.
Learn about TÜV SÜD's comprehensive end-to-end testing, certification and auditing solutions
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Following the publication of regulation (EU) 2022/112, the IVDR will be rolled out gradually.
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Extended transition period ends on May 26, 2024 for devices with valid MDD/AIMDD certification
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