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EN ISO 13485 certification

EN ISO 13485 certification



The most important thing for Medical Devices: Safety

The international, process-oriented standard ISO 13485 forms the basis for certifying quality management systems at companies that manufacture or sell medical products, or that are involved in production as part of the supply chain.

ISO 13485 builds on ISO 9001 but contains additional industry-specific requirements for medical technology. The standard is extensively harmonized with the applicable EU guideline 93/42/EEC for medical products.

ISO 13485 certification helps you document compliance with the relevant regulations for manufacturing medical products and meet all major industry requirements, even as a supplier to the medical products industry. In eases access to new markets and helps attract new customers.

Latest News

04 Jan 2018

Change of the procedure for the examination of Technical Documentations and Design Dossiers

The Medical Device Directive 93/42/EEC requires the examination of the technical documentation by the Notified Body for Class IIa and IIb devices as w...
13 Okt 2017

Revision of EN ISO 13485 - DEKRA Certification GmbH has been accredited

DEKRA Certification is accredited and introduces the most important changes

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