Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.
FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expect to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.
At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.
To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.
This template package is free to download and use for all Aligned Elements customers.
Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?
The Aligned Elements Cybersecurity Risk Assessment package contains:
- Risk assessment templates based on AAMI TIR 32, modelling Assets, Threats, Vulnerabilities and Risk Controls as Measures
- More than 30 Best Practice Cybersecurity Risk Mitigations ready to use
If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:
Cyber Security Risk Assessment Word Template