ISO 13485

ISO 13485 certification to ensure safe and quality medical devices for the global market

ISO 13485 is the international standard for the certification of a Quality Management System for the medical device industry. Defined on the basic principles of ISO 9001 and specific industry requirements, this standard is an effective tool for manufacturing companies to implement a quality management system that takes into account the entire process of design, development, manufacturing, installation and supply of medical devices.

ISO 13485 is the most popular standard for medical device quality management and is considered the “passport” to many international markets, making it a key factor in the success of any company looking to expand into global markets..

In fact, ISO 13485 certification is not only advantageous as it increases the efficiency and quality of business processes, but in some cases it is mandatory to export. This is the case in Canada, which requires mandatory ISO 13485:2016 certification for medical devices in order to be placed on the Canadian market.

In Europe, ISO 13485 has been harmonized with the three EU medical device directives (MDD, AIMDD and IVDD), so certification to the EN ISO 13485:2016 standard by an accredited body such as ECM automatically demonstrates compliance with specific requirements of these directives.

Why certify your company according to ISO 13485:2016?

  • To demonstrate its reliability in producing and placing on the market medical devices that comply with the applicable regulatory requirements through the adoption of an organizational model in line with the current regulatory framework;
  • To expand its business to international markets where the implementation of an internationally recognized quality management system is required;
  • To optimize business processes, improving efficiency and limiting waste;
  • To monitor performances according to defined parameters that allow for continuous performance improvement while reducing risk.

Ente Certificazione Macchine is an accredited body authorized to issue the certification of Quality Management Systems in accordance with EN ISO 13485:2016, to provide manufacturers, suppliers and distributors of medical devices with a professional and competent conformity assessment service. ECM will carry out all the necessary verifications and onsite audit to arrive, once non-conformities are not detected, at the issue of the certificate according to ISO 13485 standard. Our staff will also carry out the surveillance visits scheduled during the validity period of the certificate, in order to verify the existence of the requirements over time.