Critical Software GmbHCyber 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.
Our experience in a variety of safety-critical areas enables us to deliver an effective and efficient V&V for increasingly complex and competitive medical technology projects.
From defining ver...
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Software Development
We work in each phase of the medical devices’ development lifecycle and deliver turnkey solutions moving up from requirements definition, through to design, implementatio...
Risk Management & Regulatory Affairs
Regulations standardise the rules for manufacturers and is the main way to reassure healthcare providers and patients that the devices they are using are tr...
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 b...
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