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Contact SupplierBenefits of Implementing ISO 13485:2016 Certification
Ensure compliance with the requirements of the standard and more
Streamline your processes, increasing efficiency resulting in significant time and cost savings
Gain a competitive edge with our independent, globally recognized third party certification
Benefit from using a single source for all your testing and certification needs
Take advantage of our wealth of international experience, expertise and global presence in the medical devices market.
ISO 13485 is an international standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.