ISO 13485 standard

ISO 13485:2016 is a standard for the medical devices sector. This is an internationally recognised standard that sets a high level of requirements for your quality management system.

The notion of medical device

The medical devices concerned by ISO 13485 are machines, products, implants, instruments or reagents used in vitro, i. e. in the laboratory. A medical device is therefore generally used to diagnose, prevent or even treat diseases.
Within this sector, health risks are high and the regulations in force are particularly abundant - ISO 13485:2016 is an independent standard for quality management for medical devices, and is based globally on the ISO 9001 standard.

Facilitate the understanding of regulations

The standard is thus intended for distributors, subcontractors, suppliers, manufacturers, repairers and maintenance agents of medical devices.
As the health sector is undoubtedly one of the most regulated in the world, one of the objectives of ISO 13485 is to set up processes to facilitate compliance with regulatory requirements and ensure maximum product traceability.

Material vigilance and risk analysis

This standard also deals with the organization of material vigilance, i.e. the monitoring of possible incidents when medical devices are put into operation or incidents that may result from the use of medical devices once they are on the market.
Risk analysis, throughout the design and development of products, is also a major subject of the standard. The latest version of ISO 13485, in 2016, focuses particularly on risk assessment.

Qualios and ISO 13485 certification

We implement software that makes it easier for you to obtain international ISO 13485 certification, including our EDM solution and our tools to manage and improve your workflow. These solutions include multiple functionalities, such as non-conformity management or risk assessment and management. Through efficient dashboards, you maintain total control over your flow and your overall action plan.
Our solution can be 100% adapted to your activity and take into account the specificities of the medical device sector. We are at your disposal and are able to offer you a free demonstration of our software, according to your needs.