The ISO 13485 standard, currently ISO 13485:2003 Medical devices -Quality management systems – Requirements for regulatory purposes, is now the basis for quality management system compliance for most medical devices regulations worldwide.

Hence, ISO 13485:2003 certification has become the basic quality certificate for all medical device manufacturers, contract manufacturers, component manufacturers, service providers and distributors.

SGS can offer dual language (local + English) UKAS accredited ISO 13485 certification in every country in the world usually with local language auditors. As a medical device certification body with wide regulatory approval and a high reputation and with the globally respected UKAS accreditation, an SGS ISO 13485 certificate will help you achieve approval, sell your devices and reduce the number of regulatory and supplier audits you receive. An SGS UKAS accredited ISO 13485 certificate will be an actual entry requirement for some markets without local regulations, assist entry in other markets and reduce the risk of producing unsafe product.

Most SGS customers with regulatory certification also choose to have SGS ISO 13485:2003 certification and most customers with SGS ISO 13485:2003 certification choose to have SGS ISO 9001:2008 certification at no extra cost.