Medical Device Penetration Testing for Diabetes & CGM
Penetration testing for CGMs, insulin pumps, and AID systems. BLE pairing, dose-command integrity, mobile-app trust, and cloud follow-up tested end-to-end.
Aligned to FDA's February 3, 2026 premarket cybersecurity guidance.
Diabetes devices - CGMs, insulin pumps, automated insulin delivery (AID) systems, smart pens - are the highest-volume connected medical devices in the world, and uniquely combine consumer-grade BLE pairing with a dose-delivery actuator. A spoofed glucose value or a forged bolus command is a direct patient-harm event. Our pen testing for this segment focuses on three loops: sensor-to-mobile, mobile-to-pump (in AID systems), and device-to-cloud follow-up.
On BLE we test pairing mode (Just Works vs. passkey vs. OOB), session-key derivation, MAC randomization actually being enforced, and whether the device trusts a previously-bonded peer too aggressively. We test the dose-command channel for replay (can we re-send last bolus?), reorder, and out-of-range bolus rejection at the device - not just at the app. We deliberately compromise the mobile app (rooted/jailbroken, instrumented) to verify the device does not collapse to trusting whatever the app says; this is where AID systems most often fail. Finally, we evaluate the cloud follow-up stack: Tidepool-style data sharing, caregiver follow-mode, and any clinician portal - looking for IDOR, cross-tenant data leak, and weak account recovery flows that have been the published incident pattern in this space. Our reports are written to serve as risk-control evidence in your ISO 14971 file and IEC 62304 Class C software.
Layers we exercise in this engagement
The diabetes / cgm system, from the outermost cloud and clinician surfaces down to the device itself. Highlighted layers are exercised by this medical device penetration testing services.
- 01Clinician dashboard
- 02Cloud APIs Tested
- 03Mobile companion app Tested
- 04BLE pairing Tested
- 05Sensor / transmitter Tested
- 06Insulin pump (closed-loop) Tested
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Medical Device Penetration Testing Services engagement, end to end
Four phases, fixed fee, scoped to diabetes / cgm architecture from kickoff onward.
- 01
Scope + kickoff
Architecture review, attack-surface walkthrough, and threat-model alignment with your team. A written proposal within 24 hours.
- 02
Threat-model alignment
Every STRIDE entry in your threat model is matched to a planned test case so reviewers see one-to-one coverage.
- 03
Test execution
Device, cloud, mobile, BLE/RF, and OTA channels exercised in parallel by senior engineers - not a single web-app scan.
- 04
Submission-formatted report plus retest
eSTAR-format report with findings, CVSS 4.0 scores, remediation, and retests until every finding with uncontrolled risk is closed.
What we see in Diabetes / CGM medical device penetration testing services
The patterns we hit in this segment, this service, again and again.
Bonded-peer trust can extend past device pairing UX
A pump can remain bonded to a previously paired phone after the user 'forgets' the device in the app. We test whether a second app instance with the bond key can still issue commands.
Bolus command replay within a session window
A pump can reject replayed packets across sessions but not within a single connection. We test whether a captured and resent bolus during the same connection is delivered.
Mobile app as the only enforcer of max-bolus
Maximum-bolus and stacked-bolus rules can be computed in the app and sent to the pump as 'approved.' We test whether an instrumented app can bypass the checks and the pump delivers without re-validation.
CGM sensor authentication tied to a predictable serial
A companion-app session can be bound to a low-entropy sensor serial. We test whether a sniffed serial lets a second app subscribe to the same sensor stream without re-pairing.
Caregiver follow-mode access across accounts
A follow-mode history endpoint can return CGM history to an authenticated caregiver who was never granted access to that user. We test for this IDOR pattern.
Public diabetes / cgm cybersecurity history
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about in this segment - and what our scope is built to cover.
"Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
Standard Medical Device Penetration Testing Services deliverables
The same deliverables the parent Medical Device Penetration Testing Services service ships with - tuned to your diabetes / cgm architecture.
- Device, firmware, and embedded testing: hardware teardown, JTAG/UART/SPI bus access, firmware extraction and reverse engineering, and exploitation of the secure boot, debug, and update paths. Done by operators who have tested infusion pumps, monitors, surgical robots, and implantables.
- Companion app and cloud API coverage: iOS/Android binary analysis, BLE pairing/GATT attacks, REST/MQTT/gRPC fuzzing, authentication and authorization testing, and tenant-isolation checks. We test the device as patients and clinicians actually use it, not in isolation.
- penetration test reports structured for FDA premarket submissions: executive summary, methodology, CVSS-scored findings tied to your threat model, reproduction steps, and documented tester independence, scope, methods, and results. Reviewer-ready, not a generic IT security PDF.
- Remediation guidance and re-test included: written fix recommendations per finding, engineer-to-engineer support during remediation, and unlimited retests until every finding with uncontrolled risk is closed, inside the fixed fee. Accepted residual risks remain documented in your risk file.
What lands in your eSTAR submission
Documents structured for the cybersecurity attachments of your submission - no reformatting on your side.
- Device, firmware, and embedded testing: hardware teardown, JTAG/UART/SPI bus access, firmware extraction and reverse engineering, and exploitation of the secure boot, debug, and update paths. Done by operators who have tested infusion pumps, monitors, surgical robots, and implantables.
- Companion app and cloud API coverage: iOS/Android binary analysis, BLE pairing/GATT attacks, REST/MQTT/gRPC fuzzing, authentication and authorization testing, and tenant-isolation checks. We test the device as patients and clinicians actually use it, not in isolation.
- penetration test reports structured for FDA premarket submissions: executive summary, methodology, CVSS-scored findings tied to your threat model, reproduction steps, and documented tester independence, scope, methods, and results. Reviewer-ready, not a generic IT security PDF.
- Remediation guidance and re-test included: written fix recommendations per finding, engineer-to-engineer support during remediation, and unlimited retests until every finding with uncontrolled risk is closed, inside the fixed fee. Accepted residual risks remain documented in your risk file.
Standards that apply
The Diabetes / CGM baseline, plus the call-outs that matter for medical device penetration testing services in this segment.
Segment-specific call-outs
IEC 62304 Class C + ISO 14971 dose-safety risk controls
Assess each cyber finding that touches the dose pathway against your ISO 14971 risk analysis and IEC 62304 software safety classification. Cross-reference the pen test evidence from the risk file, not just attach it.
Bluetooth SIG Medical Device Profile / GATT pairing
Document which pairing method is used and why. We document the choice and its threat-model justification, not just the test result.
What's not in scope
We scope tightly on purpose. These items are either out-of-scope by design or belong in a separate engagement - we'll tell you up front, not after kickoff.
- Hospital enterprise IT network penetration testing
- Clinical efficacy or human-factors validation
- Physical security of manufacturing sites
- Source-code review (unless explicitly added as a separate engagement)
Medical Device Penetration Testing Services for Diabetes / CGM - FAQs
The questions buyers in this segment actually ask before scoping a medical device penetration testing services engagement.
Go deeper on Diabetes / CGM and premarket
A practical, ungated buyer's guide for medical device manufacturers evaluating cybersecurity partners, what goes wrong, why it costs you, and what to demand from your next engagement. Aligned to the FDA February 2026 premarket guidance.
The most common high- and critical-severity findings we surface in medical device penetration tests, what each one looks like in the field, and how to fix it before your FDA submission.
A practical, ungated guide to the threat modeling gaps that trigger FDA cybersecurity questions in 510(k), De Novo, and PMA submissions - and exactly how to close them before reviewers find them.
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
Medical device cybersecurity for nanotech neurostimulation: a fictional STRIDE threat model linking controller risks, patient harms, controls, and testing.
Other engagements for Diabetes / CGM
Teams in this segment commonly bundle these alongside medical device penetration testing services.
Keep going
Scope a Medical Device Penetration Testing Services engagement for your diabetes / cgm program.
A 30-minute discovery call with Christian Espinosa, Founder and CEO, and Kristy Kennedy, VP of Sales.