Aerstone
FDA Compliance ToolsHTMwire assessment
Aerstone is a cybersecurity consultancy offering compliance assessments, penetration testing, vulnerability management, security architecture, roadmapping, and training, with a dedicated MedTech line advertised as end-to-end FDA cybersecurity compliance for medical devices. It is a Service-Disabled Veteran-Owned Small Business with NSA-certified vulnerability assessor and PCI QSA credentials. For HTM teams this is mostly a manufacturer-facing offering: the FDA premarket cybersecurity work serves device makers, though Aerstone's broader assessment and penetration testing services can apply to healthcare organizations.
Key Features
- ✓ End-to-end FDA cybersecurity compliance for medical devices (MedTech line)
- ✓ Penetration testing
- ✓ Compliance and vulnerability assessments
- ✓ Security architecture and roadmapping
- ✓ Security training
What It Helps You Do
What Sets Them Apart
A veteran-owned consultancy that pairs NSA-certified assessment and PCI QSA credentials with a dedicated FDA medical device cybersecurity (MedTech) practice.
How Aerstone Uses AI
HTMwire's independent read on the technology — not the vendor's marketing claim.
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Frequently Asked Questions
Does Aerstone serve hospitals or medical device manufacturers?
Aerstone's MedTech line, end-to-end FDA cybersecurity compliance for medical devices, primarily serves device manufacturers preparing FDA submissions. Its broader penetration testing and assessment services can apply to hospitals, so the fit for HTM teams is partial.
What credentials does Aerstone hold?
Aerstone is a Service-Disabled Veteran-Owned Small Business (SDVOSB) and lists NSA-certified vulnerability assessor and PCI Qualified Security Assessor (QSA) credentials.
What does Aerstone's FDA medical device service cover?
Aerstone advertises end-to-end FDA cybersecurity compliance for medical devices under its MedTech line. The public site does not detail specific premarket or threat modeling methodologies, so HTM buyers should confirm exact deliverables directly.
Does Aerstone offer penetration testing for connected devices?
Yes. Penetration testing is one of Aerstone's core consultancy services, alongside compliance assessments, vulnerability management, security architecture, and training.
Sources
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