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SGS has been granted accreditation for ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes following a transition assessment done by United Kingdom Accreditation Service (UKAS).

We can now issue clients quality management certificates against the requirements of ISO 13485:2016.

If you are certified with SGS, it is recommended that you start planning your transition from ISO 13485:2003 and the associated European standard EN ISO 13485:2012 to the revised standard. New clients who wish to apply for certification to either of these standards are strongly encouraged to apply for ISO 13485:2016 certification.

For more information on transitioning to ISO 13485:2016, please contact us so we can help you make the transition under the best possible conditions and satisfy your timelines.

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SGS Hong Kong
Tel: (852) 2765 3620

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.