Jira integration that actually works - Findings become actionable tickets with CVEs and reproduction steps.
One Engagement Covers Your Compliance Needs - Our testing maps to SOC 2, HIPAA, PCI, and ISO 27001, giving SaaS teams audit-ready documentation from a single engagement.
Speed Without Shortcuts – While competitors take weeks to scope and deliver, we provide comprehensive results that fit your compliance timeline.
Transparent Pricing – Get accurate quotes in minutes, not weeks. No scope surprises or procurement bottlenecks.
Complete Regulatory Coverage
Our reports align with every major medical device security standard
FDA Guidance
Premarket & Postmarket Cybersecurity
IEC 62304
Medical Device Software Lifecycle
ISO 13485
Quality Management
Systems
IEC 60601
Medical Electrical Equipment Safety
HIPAA
Protected Health Information Security
EU MDR
European Medical Device Regulation
You're in Good Hands
“The Red Sentry team was able to deliver quick, but thorough, results for my business. Their responsiveness and findings were critical in closing a new client engagement. I am looking forward to working with them in the future.”
Craig Serold | Partner
"Complete satisfaction. Nothing less. From concept to conclusion, you are in great hands throughout the entire process."
Douglas G. | CEO
“Seamless, constructive, efficient. They are always quick to respond to customers and very easy to work with regarding scheduling.”
Ryan M. | Director of Sales
“Very good. They provided recognized credibility and gave us a clean bill of health on issues we had resolved.”
David N. | Leader of Client Delight
See How Our Pentesting Process Works
Don't let cybersecurity vulnerabilities
delay your time to market.
Book your complimentary scoping call today.
Frequently Asked Questions
How is medical device pentesting different from standard application testing?
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.
Will testing disrupt our FDA submission timeline?
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.
What types of medical devices do you test?
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.
Do your reports meet FDA cybersecurity documentation requirements?
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.
Can you test devices that aren't yet in production?
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.
What about post-market surveillance requirements?
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.
Do you test third-party components and libraries?
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.
How quickly can we schedule a test?
Most engagements can begin within 3 business days. For urgent FDA submission deadlines, we can discuss expedited testing.
What if we fail the pentest?
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.
Do you sign NDAs and BAAs?
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