ISO 13485

International Standard

ISO 13485 is an international standard quality management system specifically for medical devices, which allows medical device suppliers and manufacturers to enter the market internationally.


ISO 13485 certification process begins with a thorough evaluation from product design, manufacturing till launching to the market, as well as examine whether or not your quality management documentation fulfills the requirements of the standard. Our experienced auditor will provide extensive guidances and assistances along every stage, ensure the assessment of your quality system is carried out effectively & efficiently.


ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements and CE marking for free movement within European market. As an accredited third-party registrar, we have the authority to award ISO 13485 certification which is recognized globally.


We do the product testing and evaluation of your quality system, design and documentation in accordance with European Directives 93/42/EEC (MDD), 90/385/EEC (AIMD) , 98/79/EC (IVDD).