13485.pt

Medical Devices Consulting

Two main regulations currently regulate the placing of medical devices on the market in the European Union:

Regulation (EU) 2017/745 on medical devices and.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

These regulations preconize the implementation of activities throughout the device’s life cycle to guarantee its safety and performance.

Thus, from the design and development stage to the end of life of the medical device, economic operators must ensure a set of activities highlighted by the product’s technical file and ISO 13485 quality management system.

Examples of these activities are confirmation of compliance with essential requirements, ISO 14971 risk assessment, (pre-)clinical assessment, labelling, post-marketing monitoring, and the quality management system supported by the ISO 13485 standard.

It is recommendable that right after the idea of placing a specific medical device on the market, a diagnosis is prepared, which culminates in a plan with all the steps and resources necessary to set the device on the market. If you want to import medical devices, you also need to implement procedures established by law, as you are responsible for placing them on the market.

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