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Certification mark for quality management systems for medical devices

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Certification mark for quality management systems for medical devices



The certification mark applies to the quality management system of organizations which develop, manufacture and/or supply medical devices and the associated services. In addition to manufacturers of medical devices, this also includes organizations that offer services associated with medical devices (e.g. repairs, maintenance, sterilization).

Excluded from the scope are doctors' offices, dentists' offices, physiotherapists, podiatrists, and other health facilities if they do not offer any of the above services for medical devices.

Basis of certification:

TÜV SÜD carries out an audit to assess the quality management system of the organization to be certified for its conformity with the requirements of the standard. Certification is based on the international standard EN ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes).

This standard defines the requirements for a quality management system of organizations that need to establish their ability to develop, manufacture and supply medical devices and associated services. Certification of quality management systems according to EN ISO 13485 can be carried out separately from the approval of a quality assurance/quality management system as defined in Directives 90/386/EEC, 93/42/EEC or 98/79/EC.

However, it cannot replace this approval if it is legally required.

Key words of the certification mark:

  • RoHS

    TÜV SÜD Product Service verifies that hazardous substances in the tested products do not exceed the threshold values defined in the RoHS Directive. In this context, hazardous substances are lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE) respectively.

    The threshold value is 0.1 per cent for each of these substances, except for cadmium. The threshold value for cadmium is 0.01 percent.

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