Europe
MedTech Startup
A security assessment of a diagnostic desktop application used with the diagnostic platform, focused on protecting patient diagnostic data, strengthening application controls, and supporting the client’s FDA 510(k) documentation.
Europe
MedTech Startup
FDA 510(k)
Submission Preparation
Diagnostic
Platform
5
Security Areas Reviewed
The software layer supporting the diagnostic device was assessed with remediation guidance and documentation aligned to the client’s regulatory preparation.
The engagement supported an early-stage MedTech company’s requirements without reducing the depth of testing.
Findings were organised in a format that could translate directly into the client’s FDA submission.
Security observations were explained plainly so the internal team could understand and act without a dedicated security resource.
A human-led assessment reviewed how the desktop application handled sensitive diagnostic information.
The engagement combined practical desktop-application testing with clear evidence that could support a regulatory submission.
MedTech focused
FDA-ready evidence
The review focused on how the application handled diagnostic information, access controls, updates, and supporting components.
Review of how sensitive information was protected while moving between systems.
Review focus: Data in transit
Assessment of how diagnostic information was stored on the local machine.
Review focus: Data at rest
Review of how active user sessions were permitted to access application functions.
Review focus: Access governance
Assessment of controls used to verify the authenticity of application updates.
Review focus: Update verification
Review of supporting libraries and components used by the desktop application.
Review focus: Dependency security
Weak controls around diagnostic data, application access, and software updates could have exposed patient information or created security concerns during FDA review.
Medysec worked with the development team throughout remediation, addressing data handling, access control, and application integrity concerns while preparing records for the FDA 510(k) submission.
Encryption was enforced for data in transit and local diagnostic information was protected at rest.
Access controls were tightened to restrict functions according to the active user session.
Integrity verification was added to the application update mechanism.
Security findings and remediation records were structured for inclusion in the FDA 510(k) submission.
The desktop application was retested after remediation to verify the implemented changes.
Protected
Diagnostic Information
Data controls strengthened
Controlled
Application Access
Functions restricted by session
Verified
Software Updates
Integrity checks introduced
FDA
Documentation Supported
Security evidence prepared
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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.
