Medical device cybersecurity is a critical aspect of medical devices that are connected to a network or use software. These devices are potentially vulnerable to cybersecurity threats and require appropriate measures to protect data. This includes pacemakers, diagnostic equipment, surgical robots and more.

Medical devices that use wireless communication or are connected to the internet are particularly vulnerable to cyber threats, as they can be remotely accessed and controlled by unauthorized individuals. Cybersecurity threats to medical devices may include unauthorized access, modification, or deletion of data, malware or virus infections.

In recent years, there have been several high-profile cybersecurity incidents involving medical devices, highlighting the importance of ensuring the security of these devices. Therefore, manufacturers must implement appropriate cybersecurity measures throughout the product lifecycle, including design, development, testing and post-market surveillance, to protect against cyber threats and ensure patient safety.

Global regulatory bodies, such as the US FDA and European Union, have developed guidelines and requirements for medical device cybersecurity. However, each country has its own regulations and it is crucial for medical device manufacturers to address country-specific requirements in their regulatory submissions. 

One Realm can help you understand the US FDA pre-market and post-market cybersecurity guidance documents, the EU's MDR and IVDR cybersecurity measures, Korea Ministry of Food and Drug Safety's cybersecurity requirements and beyond.