Design Control

Design Control

Cybersecurity and Artificial Intelligence

IT security for network-compatible Medical Devices

Our experts in the field of Cybersecurity and Artificial Intelligence know the requirements, the best practice and are always up to speed. Together with you, we record - country-specific - the requirements for your products and present recommendations for the technical solutions.

Cybersecurity and Artificial Intelligence

IT security for network-compatible Medical Devices

Our experts in the field of Cybersecurity and Artificial Intelligence know the requirements, the best practice and are always up to speed. Together with you, we record - country-specific - the requirements for your products and present recommendations for the technical solutions.

Since the Cyber attacks against IT systems in the healthcare sector, the focus has shifted to IT security for network-enabled Medical Devices

A Medical Device must be protected against external attacks that result in the product no longer functioning or only functioning to a limited extent. In addition, the transmitted data must be secure and of the highest integrity in every status.

Market observation measures must also be extended to cover all possible security gaps that could potentially affect the product itself.

Ultimately, you may have considered everything, but if the health care institution has security gaps, how can you protect yourself against such vulnerabilities? This is the task of the Medical Device manufacturer in the context of risk management:

It is important that they determine and rate all conceivable safety risks while also, if possible, eliminating and communicating any remaining residual risks.

Regulatory Requirements for Cybersecurity?

Unfortunately, laws and other regulatory requirements are not always the most reliable. There are hardly any concrete requirements on how to approach Cybersecurity. A glance at FDA or MDCG guidance documents, however, helps to identify where the legislator has considered these requirements without addressing them. Thus one refers to IT security, information security, or generally to the security of Medical Devices or their design and adaptation to the state of technology.

Questions about Cybersecurity of Medical Devices - Welcome to new regulatory territory

  • Do you have software in your Medical Device or is your Medical Device a stand-alone software?
  • Is your product connected to the IT network, has its own WiFi or is self-taught (Artificial Intelligence - AI)?
  • Yet you can't find any guidelines on how to design or protect your product?
  • Every auditor or authority demands something different from you?
  • You are not sure what you are responsible for and not responsible for?

Artificial Intelligence - Medical Devices with Artificial Intelligence

Even manufacturers of Medical Devices with Artificial Intelligence are confronted with many uncertainties during development, approval and after marketing. This is because the regulations and standards do not yet contain any specific requirements for Medical Devices based, for example, on machine learning processes. Nevertheless, the safety and performance of the products must be proven and Notified Bodies require that the new technologies and procedures, in for example requirements regarding engineering and management, in risk management, and in the QM System including requirements for personnel resources be considered.

 

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

qtec as your partner

Does all of this sound overwhelming and terms like IDS, IPS, logs and sandbox are new to you? We would be happy to help you sort through the requirements and protect your product - and therefore your company - against unwanted interference.

Together with you, we will record the requirements for your products - specific to each country - and make suggestions for technical solutions.

Whether you are looking for exploits, or the correct way to document or counter them. We know your assets and will try to protect them!

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