Pen testing · Digital health & life sciences
Penetration Testing for Medical Device Makers
Penetration testing for a medical device maker has to cover the firmware, the wireless link, the companion app and the cloud back-end together, and it has to be scoped so a live test never puts a patient-connected device at risk. Engagement usually starts ahead of a licence submission, before a hospital deal closes, or as part of the verification and validation testing your quality system already expects. A finding can be routine, or it can cross the threshold into a mandatory problem report, and we help you tell the difference before it reaches Health Canada.
Reviewed by the Privacy Horizon team · Last reviewed
What you're protecting
What has to be in scope for a meaningful test
A test that only covers the web dashboard misses most of where a real device product can actually be attacked.
Firmware and the embedded operating system
The code running on the device itself, including how it handles authentication, update verification and any debug interfaces left reachable in production hardware.
BLE and wireless communication channels
The Bluetooth or cellular link between the device and its companion app or gateway, a path often overlooked by testers used to web and API work alone.
The RPM cloud back-end and its APIs
The AWS or Azure infrastructure receiving telemetry, including how it authenticates devices, isolates tenants, and exposes data to the companion app and clinical dashboards.
The companion mobile or web application
The interface patients and clinicians actually use, tested for the same class of flaws that could expose an account or the data behind it.
OTA update mechanisms
Whether firmware updates can be intercepted, tampered with, or pushed to devices without proper authorization, given how difficult these fleets are to physically recall.
Regulatory map
Why testing here connects directly to your licence and quality system
Testing is not just good practice, it intersects with what regulators and your own quality system already expect to see.
Verification and validation testing as premarket evidence
Health Canada's cybersecurity guidance expects manufacturers to verify that the security built into a device's design actually holds up, and a structured penetration test is a practical way to generate that evidence.
IEC 62304's software lifecycle expectations
Your software development lifecycle standard already calls for verification activity, and security testing fits naturally alongside the functional testing your engineering team runs before release.
The mandatory problem-reporting clock
A finding capable of causing death or serious deterioration can trigger the 10-day report, and other reportable findings the 30-day clock, so results need triage against that threshold, not just a severity score.
Hospital network-connection agreements often require it
Biomedical engineering departments increasingly want to see evidence of independent security testing before signing off on a device joining the clinical network.
What goes wrong
What a properly scoped test uncovers before someone else does
The findings that matter most here are the ones that would otherwise surface after a device is already deployed in a hospital or a patient's home.
An undisclosed backdoor in a purchased component
Undocumented capability inside a purchased chip, module or subassembly, which testing can surface before it becomes a procurement-ending discovery made by a customer or a regulator.
A service-account path into hospital networks
Remote-maintenance access that turns out to be reachable, or over-privileged, from outside the intended support path, the exact exposure biomedical engineering reviews are trying to rule out.
RPM cloud misconfiguration exposing physiological data
Access control or tenant-isolation gaps in the cloud back-end that could expose patient telemetry across accounts, a PIPEDA and PHIPA event as much as a security one.
Legacy fleet exposure once a device is already installed
Vulnerabilities that were acceptable at launch but have aged into real risk on hardware that has been running in a hospital for years without a straightforward patch path.
Our pen testing for medical device makers
What our device-and-cloud penetration testing covers
Testing scoped around your actual product architecture and constrained by patient-safety rules of engagement agreed before testing begins.
Patient-safety-aware scoping workshop
We agree in advance which functions and environments are off-limits for active exploitation when a live, patient-connected device is involved, and which can only be tested against a bench unit.
Firmware and hardware interface testing
Assessment of the embedded software, exposed ports and debug interfaces, and authentication mechanisms on the device itself.
Wireless and BLE testing
Evaluation of the pairing, authentication and data-transmission security of the device's Bluetooth or cellular link.
RPM cloud and API testing
Assessment of the cloud back-end's authentication, tenant isolation, and API surface against the same rigour applied to the device.
Companion app testing
Testing of the mobile or web application patients and clinicians use, covering the same territory as a standard application test.
Reporting mapped to your regulatory obligations
Findings triaged against the mandatory problem-reporting threshold, with an audit-ready report your RA/QA team can reference directly in submission or complaint files.
How the engagement runs
How a test proceeds around an active device product
We scope carefully before anything is touched, since the wrong test against a live device is its own kind of risk.
Step 1
Scoping workshop with engineering and RA/QA
We define in-scope systems, test environments versus production, and any patient-safety constraints before agreeing on dates.
Step 2
Test device, firmware and wireless channels
Hands-on assessment of the hardware and its communication paths, typically against bench units rather than patient-connected devices.
Step 3
Test cloud, API and companion app
Assessment of the hosted infrastructure and interfaces running in parallel with or immediately following the device-side work.
Step 4
Report and triage findings
Results are delivered with severity ratings and explicit guidance on whether any finding approaches the mandatory problem-reporting threshold.
Step 5
Retest remediated findings
Confirmation that fixes actually close the gap, particularly important for firmware fixes that may take longer to deploy across an installed fleet.
What it costs
What drives penetration test cost for a device maker
Cost tracks scope and depth, and a device product typically spans more distinct environments than a single web application: firmware, a wireless channel, a cloud back-end and a companion app each add testing days. Whether bench units are available for hands-on hardware testing, and how many device variants and firmware versions are in the fleet, also shape the estimate.
A tightly scoped cloud-and-app test costs less than a full engagement covering firmware and wireless as well, so we scope pricing after a short conversation about which systems and which driver, a submission, a hospital deal, or routine verification testing, is behind the request.
Medical Device Makers: Pen testing questions, answered
Health Canada's cybersecurity guidance expects manufacturers to verify that the security built into a device's design actually works, and penetration testing is the practical, widely used way manufacturers generate that verification evidence for a licence application, even though the guidance does not name a single mandatory test type.
Start with a scoping workshop that inventories every distinct environment, device variants, firmware versions, the wireless channel, the cloud back-end and the app, then agree which can be tested live and which need bench units. Testing days are then allocated across each environment based on its complexity.
Yes, if a finding demonstrates a plausible path to death or serious deterioration in health, it can meet the threshold for the 10-day report, and other reportable findings the 30-day report. We triage findings against that threshold explicitly so RA/QA can make the reporting decision quickly.
Rarely against a live, patient-connected unit. We test bench units, staging environments and pre-production hardware wherever possible, and agree explicit patient-safety rules of engagement before any testing touches a system connected to real patient care.
Your existing V&V testing likely focuses on functional correctness and safety under IEC 62304 and ISO 14971. A penetration test adds adversarial testing, actively trying to break authentication, isolation and update integrity, which functional testing alone does not cover.
This should not occur under a properly scoped engagement, since patient-connected devices are excluded from active exploitation by agreement. If a finding from bench testing appears serious enough to affect deployed units, we escalate it to your team immediately rather than waiting for the final report.
More for medical device makers
Other services for this niche
- Privacy & security for medical device makers — overview
- Virtual CISO
- Virtual Privacy Officer
- Incident Response Planning
- Privacy & Security Policy Development
- Privacy & Security Training
- Vendor Security Review & Questionnaire Support
- SOC 2 Readiness
- ISO 27001 Readiness
- AI Privacy Impact Assessment
- HIPAA Readiness
About this service
What's Protecting Your Business from the Next Threat?
Don't wait for a breach to expose your vulnerabilities. Let Privacy Horizon secure your data, ensure compliance, and build lasting trust.