Hands-on training risk management for medical devices

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.

Have you already familiarised yourself with the requirements for the risk management of medical devices from the European Medical Device Regulation (MDR) and the relevant ISO 14971 standard? But now you don't know how to implement the requirements in practice? 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 example product, we guide you step by step through the systematics of the most important components of risk management. Using templates, we also work with you to develop solutions that you can then later apply to your product.

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