ISO 13485 Quality Management System for Medical devices
ISO 13485 is a quality management system standard 
specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
ISO 13485: 2003 has been harmonised against the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as TÜV Product Service automatically demonstrates compliance with specific clauses in these directives.
The standard is particularly suitable to the following organisations:
- Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
- Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers.
- Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.
TÜV SÜD Product Service is accredited by ZLG in Bonn, Germany, as a Certification Body for quality management systems to ISO 13485 and is the largest Notified body covering the medical device sector (identification number 0123), having certifiedover 2,000 management systems for medical device companies worldwide.
For more information on our services for the medical device industry, please click here 
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| Benefits of certification to ISO 13485 by TÜV Product Service |
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