Hands-on training in cybersecurity risk management

You already know that risk management is the key to successful medical products. It extends from the product idea, through product development and the product launch to the end of the product life cycle.

You have already familiarised yourself with the requirements for the risk management of medical devices from Regulation (EU) 2017/745 (MDR) (“Medical Device Regulation”) and the relevant standard ISO 14971 and perhaps even implemented them successfully? 

And you know that, according to the MDR, it is no longer sufficient to consider operational safety („Safety“) alone– the theft or disclosure of data (such as patient or treatment data) is also a risk, as is the failure of diagnostics or treatment due to cyber-attacks! 

You would like a step-by-step explanation of how the legally required cybersecurity risk management can be integrated into your existing risk management system? 

Then this training is just right for you!

The real example product “BO-Score” is used to carry out the training: 

„BO-Score“ is used to assess deep emotional, physical and mental exhaustion, known as „burnout“, in adult patients aged 18 and over. The „BO-Score“ is held in the hand and measures micro-movements („trembling“). From this, conclusions can be drawn about the burnout level.

Using the sample product, we guide you step by step through our system for cybersecurity risk analyses (ARGOS). Using our templates, we work together to develop solutions that you can then later apply to your product.

Further information can be found here!

More information