Safety and quality are non-negotiable in the medical devices industry, that’s why is developed ISO 13485. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

The standard establishes requirements for all types of medical devices, which also include services and software. The medical devices range from sterile to non-sterile, invasive to non-invasive as well as non-active to active implants.

ISO 13485 has some features that are congruent with those of other management systems, especially ISO 9001. A focus is placed on complying with laws relevant to quality as well as the introduction of a risk management according to ISO 14971.

The advantages for organizations do not only include the registration aspects but also transparency of the organizations’ own performance, operations following defined processes and the fact that the organization is made aware of legal changes. Furthermore, effective actions for risk management can help to minimize and thus control risks in connection with the devices concerned.