FDA Compliance Tools

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.

Blue Goat Cyber is a MedTech-focused cybersecurity firm that helps medical device manufacturers meet FDA premarket and postmarket cybersecurity requirements. Services include penetration testing, threat modeling, SBOM generation, and submission documentation across 510(k), De Novo, PMA, and IDE pathways. The firm reports supporting 250+ FDA clearances and is an AAMI member.

C2A Security offers a risk-driven DevSecOps platform that automates cybersecurity across the device product lifecycle, from design through deployment, with a focus on regulatory compliance and vulnerability management. Medical device customers include Elekta and Ascensia, and C2A is a Siemens partner.

Product security and compliance platform for device manufacturers, covering firmware vulnerability management and FDA / EU MDR / UNECE regulatory requirements.

CyberMed.ai is a cybersecurity consulting firm that helps medical device companies build secure products and prepare FDA-ready documentation for regulatory submission and clearance.

Innolitics is an engineering and regulatory consulting firm specializing in AI-enabled medical device software (SaMD). It supports FDA compliance, including cybersecurity for 510(k) and PMA submissions, and is recognized for AI/ML SaMD work delivered for client devices.

Medical device cybersecurity firm offering the BRIDGE platform and advisory services to help hospitals build a roadmap to device-security resilience.

MedSecure USA is a consultancy specializing in FDA Section 524B premarket cybersecurity documentation for medical device manufacturers. It produces a fixed-price package of the 12 documents a cyber device submission requires, including the Security Risk Management Plan, threat model and security architecture, machine-readable SBOM and vulnerability assessment, penetration test report, labeling, and vulnerability disclosure policies, with a stated 6 to 8 week delivery. The buyer is the device manufacturer preparing an FDA submission, so for hospital HTM teams this is manufacturer-facing context rather than a direct purchase.

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.

Velentium (Velentium Medical) is an engineering-first partner providing integrated medical device development, manufacturing, and cybersecurity services for Class II and Class III devices. Its cybersecurity practice spans risk identification through implementation, positioned alongside product development and test systems from concept to commercialization.