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Medical Device Penetration Testing & Exploitability Validation

Medical device penetration testing, run as an ongoing program — not a one-time report. Your device is tested the way an attacker actually would, continuously across an annually-renewed subscription, through Aktriva's specialized testing partner — with Aktriva managing the engagement end-to-end, so your team always knows what's actually exploitable, not just what a scan flagged once.

What's included

A managed program, not billable hours

Continuous testing, not a point-in-time report

Discovery and exploitability verification run continuously across your subscription term — not a single snapshot that goes stale the moment your next release ships.

Exploitability validation

Every finding is checked against your device's real operating context to confirm whether it's actually reachable and exploitable — so your team spends its time fixing what matters, not triaging a wall of theoretical CVE matches.

Premarket and post-market coverage

One subscription covers testing through your submission cycle and continues into post-market surveillance — no separate re-engagement needed as your device evolves.

Full-stack coverage

Firmware, embedded software, cloud/SaaS-connected components, and companion apps — tested as the connected system your device actually is.

Submission-ready reporting

Findings organized and mapped to FDA/EU MDR premarket submission and post-market vulnerability management requirements, so reporting does double duty as regulatory evidence.

Why It's Different

Why medical device penetration testing is different

Medical device penetration testing goes beyond conventional IT testing. Embedded firmware, wireless protocols, and interfaces such as JTAG/UART, BLE, and USB-OTG require specialized testing, while findings must be evaluated in the context of patient safety, device performance, and data security and validated against the device's threat model.

Our testing team

Built exclusively for medical devices, not a generic pen tester

Our testing team has focused exclusively on medical devices since 2013, running test-case-based SAST, DAST, fuzzing, and penetration testing purpose-built for connected medical devices — used by six of the world's top ten medical device manufacturers, plus hundreds of emerging device makers. The team also runs its own vulnerability research, disclosing zero-day CVEs across medical devices and connected products, feeding directly back into the testing methodology.

Since 2013
Testing exclusively focused on medical devices
600+
Vulnerability reports taken through FDA review
1,000+
FDA submissions behind the methodology
1,000+
Medical devices tested and approved
Subscription plans

Choose the coverage that fits your portfolio

Both plans run on a fixed annual term and renew yearly — testing continues throughout, not just at kickoff.

Portfolio Subscription

For multiple products or business units

Concurrent testing capacity that scales with your portfolio. As one product's testing completes, the next begins — add capacity lines as your portfolio grows, with no per-test rebilling.

Ask about this plan
Optional add-on

Virtual Product Security Engineer

A named Aktriva engineer who stays engaged throughout your subscription term — not a one-time deliverable that goes unread. Your vPSE helps prioritize and implement remediation with your engineering team, and translates raw technical findings into documentation formatted for regulatory submission.

Built for teams that don't have in-house product security headcount but need ongoing support through remediation and submission, not just a report.

What a vPSE does

  • Reviews and prioritizes findings with your engineering team as they come in
  • Advises on remediation approach and verifies fixes
  • Turns technical results into regulatory-submission-ready documentation
  • Ongoing named point of contact — not a rotating support queue

Ready to see what's actually exploitable?

Tell us about your device and portfolio — we'll scope the right subscription.

Schedule a Consultation