Risk Management

The documentation, implementation and maintenance of a product risk management system is one of the obligations for medical device manufacturers.

This system’s mission is to identify, analyse and manage the foreseeable risks of any medical device in relation to its safety and operational requirements.

The system aims to mitigate as much as possible, even eliminate the possible risks associated with the product, as well as reduce as much as possible the residuals that cannot be eliminated in their entirety.

The manufacturer shall establish a risk-benefit analysis of the device and, with this, a risk acceptance criterion that allows certain risks to be assumed in relation to the benefit provided by the medical device.

Cooperation in mitigating the risks represented by medical devices already placed on the market corresponds to all the economic agents involved in the distribution and sale of the product, proportional to their degree of relationship with the risk encountered, but it is important to consider that all actors have involvement and obligations.

The risks inherent in each type of device, together with other parameters, derive the classification of medical devices, from which the main requirements applicable to the medical device are extracted.

It is, for all of the above, an iterative and constant process throughout the product’s life cycle, and must be documented and maintained throughout this time.

It will always be a planned process that must be documented in a specific risk management plan, then documented in the consequent risk file(s).