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EN ISO 13485 certification
For quality management systems, the international standard EN ISO 13485 is an independent standard and was designed for companies in the medical devices sector. You can also react flexibly to the market and the internatio- nal competition. Streamline your business processes and leverage the potentials – as an accredited certification 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.
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. Optional Pre-audit
Preliminary assessment by means of a site visit and quality management documentation check.
2. Initial certification audit: Stage 1
Evaluation of readiness of the company for certification either in an on-site audit or by a review of all required information regarding the company. A review of whether the quality management documentation meets the requirements of the ISO 13485.
Initial certification audit: Stage 2
auditing of practical implementation of the quality management system and evaluation of its effectiveness in the company.
Issue of certification
Presentation of certification 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.
In the context of the US-EU Mutual Recognition Agreement (MRA) and die FDA Accredited Persons Program (APP) we are able to perform audits, which were solely conducted by the FDA in the past!
We can also carry out certification directly for other markets on the basis of EN 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.
Contact us – we look forward to hearing from you.