Experience first-hand how you can implement cybersecurity risk management in the context of (medical) devices and software!
Effective risk management is the key for safe and effective medical devices. It encompasses every stage, starting from the initial product idea, through development and product launch, all the way to the end of the product's life.
Maybe you are already familiar with the risk management requirements outlined in Regulation (EU) 2017/745 (MDR) (Medical Device Regulation) and the relevant ISO 14971 standard in the context of safety.
But: the MDR emphasizes the need to consider not just operational safety, but also potential risks related to data security (a.k.a.: Cybersecurity) and the threats of cyber-attacks.
Would you like step-by-step instructions on how the legally required cybersecurity risk management can be integrated into your existing (safety-) Risk Management?
Then our training is tailor-made for you! We will demonstrate this process using the real-world product example "BO-Score."
Our product "BO-Score" is designed for evaluating deep emotional, physical, and mental exhaustion commonly known as "burnout" in adult patients aged 18 and above. It is a handheld device that measures micro-movements ("trembling") to derive conclusions about the level of burnout.
In our training, we apply step-by-step our system for cybersecurity risk analyses called ARGOS. Utilizing our templates, we collaboratively develop solutions hands-on, which is the most effective way of learning. These solutions can be seamlessly integrated into your risk management framework.
Let's embark on this journey together, making your (medical) device both, safe and secure for patients and practitioners alike.