![]() In Europe, ISO 13485 has been harmonized with the three EU medical device directives (MDD, AIMDD and IVDD), so the certification according to the EN ISO 13485:2016 issued by an Accredited Body as ECM, automatically demonstrates compliance with specific requirements of these directives. This is the case of Canada, which requires ISO 13485:2016 certification for medical devices in order to be placed on the Canadian market. ISO 13485 Certification is a measure of your. ![]() In fact, ISO 13485 certification is not only advantageous in terms of increasing the efficiency and quality of business processes, but in some cases it is mandatory to export your products. ISO 13485:2016 applies to design, development, production, installation and servicing of medical devices. ISO 13485 is the most popular standard for quality management of medical devices and it is considered the “passport” for many international markets, making it a key factor for the success of any company looking to expand into global markets. Defined on the basic principles of ISO 9001 and specific industry requirements, this standard is an effective tool for manufacturers to implement a quality management system that includes the entire process of design, development, production, installation and supply of medical devices. ![]() ISO 13485 is the international standard for the certification of a Quality Management System for the medical device industry. ISO 13485 certification to ensure safe and quality medical devices for the global market ![]()
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