Stratigos Security
FDA Compliance ToolsHTMwire assessment
Stratigos Security is a medical device product security consultancy that provides FDA-aligned cybersecurity testing for device manufacturers, including threat modeling, penetration testing, code and binary analysis, and documentation formatted for premarket submissions. The firm positions itself as engineering-first and regulatory-aligned, stating its staff advised on and drafted FDA premarket and postmarket cybersecurity guidance. This is a manufacturer-facing offering: the buyer is the device maker preparing an FDA submission, so the value for hospital HTM teams is contextual rather than a direct purchase.
Key Features
- ✓ FDA-aligned cybersecurity testing for medical devices
- ✓ Threat modeling and exposure-surface scoping
- ✓ Penetration testing with custom and emergent techniques
- ✓ Static/dynamic code analysis, fuzz testing, and vulnerability chaining
- ✓ Premarket submission documentation aligned to FDA guidance
What It Helps You Do
What Sets Them Apart
An engineering-first product security firm whose staff state they advised on and drafted FDA premarket and postmarket cybersecurity guidance.
How Stratigos Security Uses AI
HTMwire's independent read on the technology — not the vendor's marketing claim.
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Frequently Asked Questions
Does Stratigos Security work with hospitals or device manufacturers?
Stratigos Security is a medical device product security consultancy whose buyer is the device manufacturer preparing an FDA submission. For hospital HTM teams it is useful context on a device's security testing, not a service hospitals typically purchase directly.
What FDA cybersecurity services does Stratigos Security provide?
It provides FDA-aligned threat modeling, penetration testing, static and dynamic code analysis, fuzz testing, vulnerability chaining, and documentation formatted for premarket submissions.
What makes Stratigos Security different?
The firm positions itself as engineering-first and regulatory-aligned and states its staff advised on and drafted FDA premarket and postmarket cybersecurity guidance, giving it regulator-side perspective on submission expectations.
Is Stratigos Security a Medcrypt partner?
We could not verify a Medcrypt partnership. Neither the Stratigos Security site nor a Medcrypt partners listing publicly confirms it, so we are not stating it as fact.
Sources
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