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The certification mark applies to the quality management system of organisations which develop, manufacture and/or supply medical devices and the associated services. In addition to manufacturers of medical devices, this also includes organisations that offer services associated with medical devices (e.g. repairs, maintenance, sterilisation).
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.
TÜV SÜD carries out an audit to assess the quality management system of the organisation 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 organisations 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.
The basis of certification (see basis of certification) is the international EN 13485 standard. The processes relevant for certification and related to the supply of medical devices and/or services associated with medical devices are subject to continuous surveillance.
This is one of the basic requirements for certification including the award of the TÜV SÜD certification mark. Certification always includes an on-site audit at the relevant sites. TÜV SÜD Product Service verifies that the certified organisation/organisation to be certified meets the requirements set forth in EN ISO 13485.
The requirements particularly concern design and development, production, installation and servicing and maintenance of medical devices.
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