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What are ISO norms? Is ISO applicable to medical devices?

2 October 2018 - 16:09

There are plenty of ISO norms (International Organization for Standardization) who, depending on the industry and activities, aim to define specific requirements to standardize all products as much as possible. The 9001 norm concerns the implementation of System Quality Management(SQM), which allows to increase on a constant basis client satisfaction whilst guaranteeing that their products and services are compliant.

The ISO 13485 norm for Medical Devices

The ISO 13485 norm is specific to medical devices and is a declination of the 9001 norm that has been adapted to fit the health sector. To be able to obtain this type of certification a company needs to collaborate with an independent certification agency to implement all necessary procedures that allow to guarantee the quality of the product, from its conception to the recycling phase.

True added value

This certification is not really obliged to be able to commercialize products, but complying to it is strongly recommended when you want to put a medical device on the market. This certification guarantees that the company that is in charge of the development of the product follows a quality control process that is owned by an independent organism, which can be an absolute added value. In a certain way this certification also simplifies the CE labeling of concerned products.

Multiple requirements

This certification requires the implementation of procedures with regards to the respect of this regulatory requirements, knowledge of special techniques and processes, risk analysis during the lifecycle of the products, clinical tests and follow-up, the organization of the monitoring of the devices once they have been put on the market (medical device vigilance procedure), and the traceability of each device that has been sold.

The’ experts can help you to determine whether this certification could make sense for your product and can help you with implementing all the necessary measures to obtain this certification, more precisely via the MedTech Accelerator ®.

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