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ISO 13485:2003

SGS ISO 13485 certification will help you achieve approval, sell your devices more effectively and reduce the number of supplier audits you receive.

The ISO 13485 standard, currently ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes, is the basis for regulatory compliance in your local market, and most export markets. Certification demonstrates your commitment to meeting your customers’ requirements.

At SGS, we offer a global service for UKAS accredited ISO 13485 certification. Our worldwide presence means your audit will normally be carried out by local-language auditors.

Who needs to achieve ISO 13485 certification?

ISO 13485:2003 is applicable to all manufacturers and providers of medical devices, components, contract services and distributors of medical devices, but note that this standard is issued in Europe as EN ISO 13485:2012 with requirements unchanged.

Our wide range of regulatory approvals, United Kingdom Accreditation Service (UKAS) accreditation and close links with medical authorities make us a natural partner to meeting your certification requirements. For many markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for technically correct advice and certification, we have the expert knowledge and global network of auditors to help you achieve your objectives.

Build strong foundations for your medical devices certification strategy with an SGS UKAS accredited ISO 13485:2003 audit, the basis for regulatory approvals such as ROC Taiwan and Australia.


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