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  • Certification according to ISO 15378:2006

ISO 13485 certification

For quality management systems, the international standard ISO 13485 is an independent standard and was designed for companies in the medical devices sector.You too can react flexibly to the market and your international competition. Streamline your business processes and leverage the potentials – as a “notified body”, we provide you with all the support you need!

 

This international standard defines requirements of quality assurance systems for the design/development, production, customer service and assembly of medical devices. It covers all GMP principles (GMP = Good Manufacturing Practice) that apply for the manufacturing of medical devices. In addition to the ISO 9001 requirements, a series of additional criteria must be fulfilled for ISO 13485.
Leverage certification in accordance with an internationally recognised quality management standard for the medical devices industry to achieve global market access.

Four steps to success

1. Pre-audit
   Preliminary assessment by means of a site visit.
2. Document review
   A review of whether the quality management documentation meets the requirements of the standard.  
3. Certification audit
   Practical use of the quality management system and evaluation of its effectiveness.  
4. Issue of certificate
   Presentation of certificate following fulfilment of all criteria. Certification of compliance with the standard and of the integrity of the quality management system.

We have sound international experience in the area of medical devices. We are accredited by the ZLG to certify QM systems in accordance with EN ISO 13485 and are also active as a “notified body” for medical devices. Our certificate is recognised worldwide. Utilise our certificate to secure competitive advantages around the globe.

We can also carry out certification directly for other markets on the basis of ISO 13485. Our specially trained audit teams are approved by Health Canada, the Japanese Ministry of Health (MHLW) and the Taiwanese Health Authority (DOH), for example. In combination with other audits, you can save time and money.

We also have accreditations for the US MRA/AP program which enables to carry out inspections in place of the US authority FDA.

Contact us – we look forward to hearing from you. 

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