Total Documentation for Product Certification


Product Certification - CE Mark, ISO 13485

Product Certification is the process of providing third party assurance that products comply with specified requirements stipulated in the relevant national standards, regulations or specifications. It confirms that products have passed specified performance and quality assurance tests. Product Certification allows you to demonstrate that you perform internal quality monitoring and manage every detail of the production of a product.

CE Mark Certification

CE Mark is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing applicable European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. CE Mark Certification allows you to legally market and distributes your product within the European Market, and declares that your product complies with all applicable European Directives and Regulations.

ISO 13485:2016 Certification

ISO 13485 is internationally recognized standard specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The ISO 13485:2016 certification provides a practical foundation for manufacturers to address the medical device directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

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