Date & Time
- from
- 19/03/202609:00 am
- until
- 19/03/202616:00 pm
- duration
- 7hours
You already know that risk management is the key to successful medical devices. It extends from the product idea, through product development and the product launch to the end of the product's life.
Have you already familiarised yourself with the risk management requirements for medical devices from Regulation (EU) 2017/745 (MDR) ("Medical Device Regulation") and the relevant ISO 14971 standard and perhaps even implemented them successfully?
And you know that, according to the MDR, it is no longer sufficient to consider operational 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!
Would you like a step-by-step explanation of how the legally required cybersecurity risk management can be integrated into your existing risk management?
This training is just right for you!
The real example product "BO-Score" is used to conduct the training:
"BO-Score" is used to assess deep emotional, physical and mental exhaustion, known as "burnout", in adult patients aged 18 and over. "BO-Score" is held in the hand and measures micro-movements ("trembling"). This allows conclusions to 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 transfer to your product.
The above texts, or parts thereof, were automatically translated from the original language text using a translation system (DeepL API).
Despite careful machine processing, translation errors cannot be ruled out.