The ISO 13485 standard defines the requirements for Management systems that ensure compliance with regulations for countries all around the world, and is the only international standard exclusively dedicated to medical devices.
It is aimed at manufacturers and suppliers of medical devices, to which it offers the possibility of obtaining significant operational improvements. It is indispensable for the companies producing sanitary articles who export their products in the global market.
Some of the additional requirements concern the definition of controls, the monitoring of processes (including environmental controls), the special processes, the traceability, the recording and the retention of regulatory acts, which are particularly critical for the medical device industry.
ISO 13485 provides a framework for monitoring and measuring process and operational performance related to the design, production and distribution of medical devices, ensuring an improvement in efficiency and therefore in customer satisfaction. It also ensures that the organization is updated on the specific mandatory requirements associated with medical devices and supports compliance with national and international directives.
ISO 13485 is aimed at:
- Companies that currently produce medical devices under their own brand and who wish to place these devices on the European Union market under their own name;
- Companies that design, produce and assemble medical devices and in-vitro diagnostic medical devices;
- Companies that produce components of medical equipment;
- manufacturers of in vitro diagnostic devices who want to stand out and comply with regulatory requirements to enter the EU.
Your customers can buy your medical devices being aware that you have the necessary skills to continuously provide quality products and services, compliant with the requirements of national and international regulations.