Medical-device cybersecurity
Medical-device cybersecurity
A device’s connectivity, software and maintenance interfaces can affect its safety and performance. Sytance helps the team analyse those risks, keep the supporting design and test records, and prepare cybersecurity documentation for FDA and EU MDR work.
Architecture review
What depends on this connection?
Describe which measurements and commands cross the interface, who can send them, and how interrupted or modified data could affect clinical use.
An example for discussing architecture. Clinical functions and safety consequences require device-specific assessment.
Prepare for the intended market
A shared technical foundation. Different regulatory files.
Sytance supports medical-device evidence records and document preparation for FDA and MDR work, alongside IEC 81001-5-1 product security activities. Select a framework to see the focus of each file.
The manufacturer confirms device classification, applicable obligations and the assessment route. Generating a document does not establish regulatory clearance or conformity.
FDA cybersecurity evidence
Prepare the device-specific architecture, analysis and supporting records for the relevant submission. Section 524B obligations apply to qualifying cyber devices.
Security architecture
Security architecture and threat modelling for the device system
- Analysis scope
- Intended use, software and connected systems
- Supporting records
- System views, interfaces and trust boundaries
Connect cybersecurity to clinical use
Follow the attack through to its possible clinical effect
An attack scenario becomes useful when it explains which device function could change, under what conditions, and how the proposed measure would be verified.
A service account changes a protected alarm setting
The alarm is issued under different conditions
Staff may receive the clinical warning later
Limit configuration changes to authorised roles and protect the saved settings.
Call the configuration interface with a lower-privilege account; read back the setting and check that the alarm behaviour is unchanged.
Planned activity · execution results requiredKeep the file useful after release
A new vulnerability calls for a device-specific decision
Component information, architecture and existing controls help the team assess a new finding. Record the affected version, clinical implications, chosen action and information needed by users or service teams.
Explore component and vulnerability recordsIdentify the delivered component
Use the SBOM and release information to identify the component version and where it is used in the device.
Review the impact on this device
Check reachability, configuration, existing controls and the possible effect on safety and performance.
Record the action and follow-up
Keep the decision, update or mitigation, verification records and user communication together.
Medical-device cybersecurity knowledge
Browse the collectionStart with the device, market and existing records
Bring the intended use, architecture, software inventory and current test material. We can discuss how to organise the work in Sytance and which analysis or testing needs specialist support.
