India
Life Sciences & MedTech
A security assessment spanning a BLE-enabled medical device, companion mobile application, web component, and cloud environment, with remediation and compliance documentation prepared for the client's FDA cybersecurity submission.
India
Life Sciences & MedTech
Connected Medical Device
BLE-Enabled Technology
FDA 510(k)
Submission Preparation
Device + Mobile + Cloud
Multi-Layer Assessment
The client needed thorough testing across connected technology and documentation that could directly support the regulatory process.
The assessment documentation was structured to map cleanly to the requirements of the FDA submission.
A human-led approach assessed BLE communication and firewall configuration beyond automated scanning.
Findings across device, mobile, web, and cloud components were organised and easy to track.
The engagement supported the multi-asset scope without requiring the client to narrow what was tested.
The assessment brought the device, mobile application, web component, and cloud environment into one coordinated security review to support FDA preparation.
MedTech focused
FDA-ready evidence
The review focused on device communication, cloud access, mobile data protection, and transport security.
The device's Bluetooth Low Energy communication was assessed for authentication and connection security.
Review focus: Device security
The cloud environment was reviewed for unnecessary exposure and access configurations.
Review focus: Cloud access
Local storage within the companion application was assessed for protection of synced information.
Review focus: Data protection
Communication between the device and cloud backend was reviewed for appropriate transport protection.
Review focus: Transport security
Weaknesses across device communication, local storage, and cloud connectivity could have created opportunities for unauthorised access to device communications and health-related information during the FDA submission process.
Qualysec worked with the client’s engineering team across the connected environment, providing remediation guidance and preparing documentation for the FDA cybersecurity submission.
Proper pairing authentication was introduced to strengthen device communication and prevent unauthorised connections.
Cloud firewall rules were tightened to remove unnecessary exposure and restrict access to required services.
Local storage within the mobile application was encrypted to better protect information synced from the device.
Encryption was enforced between the medical device and its cloud backend to protect information during transmission.
Findings and remediation work were documented in a format suitable for the FDA cybersecurity submission.
Secured
Device Communication
Controls strengthened around intended connections
Restricted
Cloud Access
Unnecessary exposure removed
Protected
Mobile Data
Stored device information secured
FDA
Submission Supported
Security documentation prepared
Get In Touch
Whether you are preparing any regulation or standards submission, testing a connected device, or assessing risk across a MedTech platform, we can start with a scoping call.
