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Medical Device Security Testing
Connected medical devices must be secure to be safe. We test devices, companion apps and cloud platforms, and produce evidence that supports regulatory submissions and hospital procurement reviews.
Why teams choose Adiroha
- Manual-first testing, not scanner dumps
- OSCP, OSWE and CEH certified testers
- Findings mapped to ISO 27001, SOC 2 and PCI DSS controls
- Retest and closure letter to prove fixes
Scope
What we cover
- Device, firmware and interface testing
- Companion app and cloud platform testing
- SBOM and third-party component risk
- Threat modeling for patient-safety impact
- Alignment to FDA premarket cybersecurity guidance
- Support for IEC 62304 and IEC 81001-5-1 processes
Deliverables
What you receive
- Security test report suitable for regulatory files
- SBOM and vulnerability assessment
- Threat model and risk documentation
- Retest and closure evidence
How we work
Discover. Assess. Remediate. Validate.
Discover
Agree scope, assets, test windows and rules of engagement. Every project gets a unique audit code for tracking.
Assess
Manual-first testing aligned to recognised standards, with critical issues flagged to you immediately.
Remediate
Findings ranked by business impact, with clear fix guidance and a walkthrough with your engineers.
Validate
We retest your fixes, update the report and issue a closure letter you can share.
FAQ
Common questions
Can your report support an FDA submission?
Our testing and documentation are structured to support premarket cybersecurity requirements. Final submission strategy stays with your regulatory team.
Do you test hospital deployments?
Yes. We can assess how devices are deployed and segmented in a clinical network.
Which devices do you test?
Connected diagnostic, monitoring and therapeutic devices, wearables, and the software and cloud platforms that support them.
Do you provide an SBOM?
Yes. We can generate or validate a software bill of materials and assess its components for known vulnerabilities.
Can you support post-market security monitoring?
Yes. We can set up vulnerability monitoring for device components and help you plan updates and disclosures.
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Learn moreTalk to a specialist about Medical Device Security Testing.
A free 30-minute consultation to understand your scope and timeline. We follow up with a fixed proposal.