Medical device testing requires specialized knowledge of FDA cybersecurity guidance, clinical workflows, and patient safety considerations. We test for vulnerabilities specific to healthcare environments including HL7/FHIR interfaces, DICOM protocols, and real-time patient monitoring systems. Our reports map directly to FDA premarket submission requirements and IEC 62304 standards.

An API Penetration Test assesses the security of an Application Programming Interface by identifying vulnerabilities such as authentication flaws, improper access controls, data leakage, and injection attacks. This type of test ensures that APIs are resilient against potential cyber threats and unauthorized access.

We test all classes of connected medical devices including implantables, surgical robotics, patient monitors, infusion pumps, diagnostic imaging systems, mobile health applications, and SaMD (Software as Medical Device). Our team has experience with both standalone devices and those integrated with hospital networks.

Yes. Our reports are specifically formatted to meet FDA premarket cybersecurity guidance requirements. They include threat modeling, vulnerability assessment results, and mitigation strategies that map directly to FDA's documentation expectations for 510(k), PMA, and De Novo submissions.

Absolutely. We regularly test prototypes, beta versions, and pre-production devices. Early testing helps identify architectural vulnerabilities before they become expensive to fix. We can work with your engineering team throughout your development lifecycle.

We offer ongoing testing programs that satisfy FDA post-market cybersecurity requirements. This includes quarterly or annual assessments, SBOM monitoring, and emerging threat analysis to maintain your device's security throughout its lifecycle.

Yes. We perform comprehensive Software Bill of Materials (SBOM) analysis, identifying vulnerabilities in all third-party components, libraries, and dependencies. This is critical for FDA submissions and ongoing vulnerability management.

Most engagements can begin within 3 business days. For urgent FDA submission deadlines, we can discuss expedited testing.

There's no "pass" or "fail" – we identify vulnerabilities and provide prioritized remediation guidance. We offer free retesting for critical findings and can provide attestation letters once vulnerabilities are addressed. Our goal is to strengthen your security posture, not create roadblocks.

Yes. We routinely sign NDAs, BAAs (Business Associate Agreements), and other confidentiality agreements. We understand the sensitive nature of medical device IP and maintain SOC 2 Type II certification for our security practices