Devices that reach the network
Pumps, monitors, and diagnostic tools with a network path become part of the attack surface.
For MedTech
Penetration testing and security audits for MedTech
AI security assessments for connected medical devices, device software, and the platforms around them: static analysis, dynamic testing, API audits, and AI security in one run. Validated findings and audit-ready evidence in hours, not weeks.
Why MedTech needs security testing
Connected devices, companion apps, and cloud platforms carry clinical data and, more and more, control over what a device does. One flaw can reach the hospital floor, and regulators, hospital procurement, and insurers ask for evidence that you test before they buy.
Software as a medical device
Firmware, mobile companions, and cloud backends all need testing, and the seams between them move with every release.
Evidence in procurement
Hospital purchasing and notified bodies expect testing reports from your technical documentation, not promises.
Evidence your auditors and regulators can use
Assessment reports carry validated findings, retested fixes, and structured evidence for your technical documentation. AISafe Labs does not certify compliance; it supplies the technical testing behind it.
EU CRA
Products must ship free of known exploitable flaws, pass regular security testing, and stay supported for at least five years, with 24-hour reporting of exploited flaws.
GDPR
Article 32 requires regular evaluation of security measures, but it leaves the testing method risk-based.
ISO 27001
Auditors use testing evidence to assess technical vulnerability management and security testing controls.
HIPAA
The Security Rule requires risk analysis and periodic technical evaluation, not a named pentest.
What we test
Pick the depth that fits your device software and platform. Every assessment reports only validated findings.
Source Code Audit
Identify all the vulnerabilities throughout your application, including business logic flaws, authorization weaknesses, architectural issues, insecure data flows, and implementation errors directly from the source code.
White-Box Pentest
Combine source code analysis with testing against a live environment to uncover vulnerabilities, execute real exploits, validate impact, and identify attack paths that only emerge in running systems.
Black-Box Pentest
Assess your application from an attacker's perspective by discovering, and chaining vulnerabilities in a live environment, including permission bypasses, authentication flaws, and privilege escalation paths.
Security testing across the MedTech stack
One assessment covers the layers a MedTech product is built from: the code, the running product, the APIs that connect device, cloud, and hospital, and the AI on top.
Static analysis (SAST)
Reads source without running it. We audit device software, backends, and mobile companions for hardcoded secrets, injection, unsafe deserialization, and broken authentication.
Dynamic analysis (DAST)
Tests the running product. Companion apps, web portals, and device web interfaces get authenticated testing for injection, XSS, broken access control, and session flaws.
Device and API security testing
The APIs between device, cloud, and hospital systems are tested for IDOR, excessive data exposure, and weak authorization, the flaws that leak one patient record into another.
AI security testing
We test the AI in your product, clinical decision support, imaging analysis, and copilots, for prompt injection and data leakage. AI agents run the assessment itself.
Integrations
Point AISafe at your repositories and trackers. Assessments start from the workflow your team already runs.
- GitHub
- GitLab
- Bitbucket
- Jira
- Linear
- Slack
- Microsoft Teams
- Google Workspace
Works best with
The clouds, runtimes, and messaging layers connected devices usually sit on are the ones our agents test every day.
- AWS IoT
- Azure IoT
- Google Cloud
- Docker
- Kubernetes
- MQTT
- PostgreSQL
- MongoDB
- React Native
- Python
- Java
- .NET
Software our assessments are built to secure
Examples of the products our assessments target. We name them to show the kind of software we test; they are not customer references.
International medtech leaders
- Medtronic
- Philips
- GE HealthCare
- Siemens Healthineers
- Abbott
Romanian health platforms
- Regina Maria
- MedLife
- SanoPass
- Sanador
Popular Romanian tech
- UiPath
- Bitdefender
- eMAG
Security that holds after the report
The threat model built during the assessment keeps working once the code starts changing.
Pull Request Review
New code is evaluated against the threat model established during the assessment, preventing changes that weaken permissions, break trust boundaries, or violate critical security invariants.
Endpoint Monitoring
Endpoints, permissions, and trust boundaries discovered during the assessment are continuously validated, ensuring security controls remain enforced as applications evolve over time.
Frequently Asked Questions
Yes. Scope the device software, companion apps, cloud platform, and the APIs between them. We test exactly the systems you approve and nothing else, and most assessments run without physical hardware in the loop.
The EU Cyber Resilience Act and the Medical Device Regulation expect security risk work and technical evidence. Our reports contain validated, reproducible findings and retested fixes that feed that documentation. AISafe Labs does not certify compliance.
All data, including source code and findings, is stored encrypted. Assessments do not need real patient data, and you can permanently delete any data from the platform at any time.
You define the scope and the assessment starts immediately. Results arrive in hours instead of weeks, and you can rerun it after fixes to confirm they hold before the next release.
Each fix can be retested in the same scope. The report then shows the full cycle: finding, fix, and confirmation, which is what auditors and notified bodies ask to see.
Connect GitHub, GitLab, or Bitbucket and start an assessment from the code you already ship. Findings can flow to Jira or Linear and alerts to Slack or Microsoft Teams, so fixes stay in the tools your team uses.
Can't find your answer here? Get in touch