Verify the safety and performance of your medical device as well as its clinical benefits – all throughout its life cycle.

Risk in the field of medical devices

According to ISO 14971, risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.

The use of a medical device carries an inherent level of risk even if the associated risks have been mitigated to an acceptable level. Whether the overall risk of a medical device is deemed acceptable or not also depends on the benefit it brings to the patient.

For manufacturers it is essential to implement risk management in their technical documentation –not only in times of initial or renewal application for CE certification, but as an integral part of an effective and intelligent quality management system that considers the entire life cycle of a product.

Your partner for risk management

Given the importance and complex nature of the task, it can be a challenge to even know where to start. ISO 14971 is a worldwide recognized standard for product-specific risk management and provides an excellent guideline for manufacturers. However, achieving a shared and equal understanding within the risk management process among all stakeholders might be difficult due to differences in both opinions and interests.

With our sound knowledge and as your independent partner, THE FORCE expands your views and assists you in tackling the complexities of risk management to guarantee compliance of your risk management and your medical device.

Risk management as part of your transformation strategy

Risk management hardly ever is an isolated process within your organization. It can therefore be worth it to take a step back and check whether the need to update your risk management is part of a bigger picture: If that’s the case, you might be faced with an urgency to transform your existing quality management system and to boost the interactions within your company – in which our Transformation and Strategy team is ready to support you.

Reach out

to tackle the complexities of risk management.