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Critical Software GmbH

Service Provider

Critical Software GmbHCyber security for medical devices and medical technology companies

Cyber security for medical devices and medical technology companies

Cyber Security

The security of embedded devices is a pressing concern for society.

Medical devices are no different from other computer systems when it comes to their vulnerability to security breaches, and this can easily impact the safety and effectiveness of the device itself. Therefore, it isn’t surprising that news about cybersecurity breaches and attacks to the healthcare industry is becoming increasingly common. 

Our approach to tackling the cyber security challenges facing the medical devices industry is two-pronged, focusing on supporting both the security of medical devices and systems, and the security of information contained within them.

On the one hand, there’s the constant exchange of medical information between multiple stakeholders, like manufacturers, healthcare providers and suppliers, so robust measures are needed to ensure that there are no security breaches whenever data is exchanged.

On the other, security in embedded devices is becoming a greater problem. Now more than ever before, medical devices can interact with each other and other networks, without human intervention or supervision. The rate at which new, connected and embedded systems are entering the medical devices market is now so rapid that the impact of these new technologies has become unpredictable. Complex security barriers need to be established, which can be a challenge for manufacturers.

We have applied our experience with safety-critical applications to medical devices in order to develop a full response to the need for medical device cyber security.

Our integrated approach covers the entire spectrum of embedded cyber security activities. These range from:  

  • Preparing corporate level Security Management Systems 
  • Defining secure development processes covering integrated electronic systems and software development cycles
  • Implementing secure embedded systems and enterprise applications for medical devices

Our approach can be top-down including all of the layers listed, or depending on the client’s needs, a combination of the three.

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Checking the health of medical devices
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Risk Management & Regulatory Affairs
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