ISO 13485 Quality Management System for Medical Devices

ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
ISO 13485: 2016 has been harmonised against the three EU Medical Devices, so certification to this standard by an accredited certification body such as AQSCERT Product Service automatically

demonstrates compliance with specific clauses in these directives

Why certy your quality management system?

The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g Active implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

The current European medical device quality system standard is EN ISO 13485:2016. When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous – it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2016.
Who is the standart for?

• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
• Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers.
• Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

Your benefits at a glance?

• Enhanced efficiency and marketability – Formal certification of your quality management system will help you to market your products and services and to improve the efficiency of your organisation.
  • Expert partnership – Our experienced audit team has the goal of adding value to your business by identifying improvement opportunities in addition to risks from any non-conforming areas.