The ISO 13485 standard “Medical devices – Quality Management Systems – Requirements for regulatory purposes” provides specific internationally recognized requirements to certify the Quality Management System for medical device companies. It involves aspects of the ISO 9001 standard and additional requirements specific to the medical field, and it has been harmonized in compliance with the relevant European Directives – Medical Devices, In Vitro Diagnostic Devices and Active Implantable Devices.

 Why certify your QMS, according to ISO 13485?

 Certifying a product according to the scheme established by the ISO 13485:2016 enables manufacturers to demonstrate their ability to provide medical devices and related services that meet market standards and applicable regulatory requirements.

 What benefits does the QMS certification according to ISO 13485:2016 provide?

 QMS certification according to ISO 13485:2016 has a double advantage: on the one hand, it provides a practical tool to face the conformity assessment process of the product to the regulations, on the other hand, it shows the company’s commitment to quality and safetyof their medical devices.

Quality Management System certification according to ISO 13485:2016 requirements allows to:

  • identify an efficient method for managing business processes, reducing waste of time and resources
  • monitor safety, efficiency and performance of the entire supply and distribution chain
  • facilitate the access to global market, as the ISO standards are internationally recognized and, in some extra-EU countries, necessary
  • provide safe, high-quality and compliant with regulations medical devices, which meet the expectations of the market.

The conformity assessment of the Quality Management System according to the EN ISO 13485:2016 standard can be carried out by an Accredited Certification Body as Ente Certificazione Macchine.

Ente Certificazione Macchine, as well as Notified Body for Medical Devices Directive 93/42/EC, is accredited by Accredia for the certification of Quality Management Systems according to ISO/IEC 17021. In this role ECM, already accredited for the certification of the Quality Management System of Medical Devices according to EN ISO 13485:2012, is able to perform all the compliance assessment activities of the company quality management system, according with the latest version of the standard ISO 13485:2016.

Contact us for more information at info@entecerma-usa.it