ISO 13485 certification & auditing services

ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) designed for the medical device industry.

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 facilitates meeting market access requirements in several major jurisdictions worldwide.

The quality of medical devices directly impacts their effectiveness and the safety of patients, users, and other people. For these reasons, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system.

See below how each region harmonizes regulatory schemes to ISO 13485:

• United States: Following February 2, 2026, manufacturers seeking to market devices in the US must comply with the FDA new Quality Management System Regulations (QMSR), which incorporate ISO 13485:2016 by reference.
• European Union: Requirements of EN ISO 13485 have been harmonized under the EU’s Medical Device Regulation and In-Vitro Diagnostic Medical Device Regulation . Certification to EN ISO 13485 by an accredited certification body confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding requirements of these regulations.
• South Africa: ISO 13485 certification is recognized by the South African Health Products Regulatory Authority for medical device compliance and market access.
• Singapore: ISO 13485 certification to the Singapore Accreditation Council (SAC) scheme is recognized to support both regulatory compliance and market access.

Benefits of obtaining ISO 13485 certification

• Improve quality and transparency in manufacturing
• Ensure quality, safety, and performance of your medical devices
• Strengthen brand reputation, consumer trust, and satisfaction
• Prevent costly nonconformities and product recalls

Unmatched Global Expertise & Recognition: As one of the leading global management certification bodies, TÜV SÜD provides ISO 13485 certification for quality management systems in the manufacture of medical devices.

Deep Medical Device Expertise: Our audit team consists of professionals with the skills and experience needed to accurately assess the compliance of your management system.

Official Regulatory Recognition Where It Matters: TÜV SÜD provides comprehensive regulatory and certification services across all major medical device markets worldwide, including:

• MDSAP Participating Regulatory Jurisdictions (US FDA, Health Canada, Brazil ANVISA, Japan PMDA, Australia TGA): Recognized Auditing Organization able to conduct a single regulatory audit that satisfies the requirements of five major markets.
• European Union: One of the largest Notified Bodies for EU MDR and IVDR compliance
• Asia Pacific: Accredited services across Japan, Singapore, Korea, India, Australia, Malaysia, Taiwan, and Ukraine
• Africa: Officially recognized by SAHPRA in South Africa for issuing ISO 13485 certificates