Case Studies
Learn how we’ve helped thousands of devices get to market. These case studies highlight some of our most impactful collaborations — moments where we met clients where they were, helped them overcome critical challenges, and unlocked the progress they needed to move forward with confidence.
Wearable Insulin Pump – Guiding a Non-US Medical Device Manufacturer Through FDA Regulatory Clearance After Initial Rejection
Regulatory Submission Support Software & Firmware Testing Hardware Testing
Guiding a non-US medical device manufacturer through FDA cybersecurity gaps with analysis, revised risk assessments, testing—achieving successful 510(k) clearance.
Cardiovascular Patient Monitoring Solution – Strengthening Device Security and FDA Readiness Through Trusted Components and Secure Firmware Boot
Software & Firmware Testing Hardware Testing Software Design & Development
Improved cardiovascular device security and ensuring FDA readiness through trusted components and secure firmware boot.
MRI Drug Infusion Pump – Securing a Custom Radio Protocol for Regulatory Approval
Regulatory Submission Support Software & Firmware Testing
Secured MRI drug infusion pump’s proprietary 2.4 GHz radio protocol through reverse engineering, cryptographic audit, and detailed documentation.
Surgical Robotics System – Critical Vulnerability in a 3rd-Party Peripheral
Hardware Testing Security & Data Privacy
Remediating a critical third-party vulnerability in surgical robotics, ensuring 510(k) readiness and safeguarding clinical operations from cybersecurity risks.
Home Renal Dialysis System – Secure Connectivity from Patient’s Home to the Clinical Cloud
Security & Data Privacy Software Design & Development
Developing a secure connection from a patient’s home dialysis system to the clinical cloud, ensuring compliance with patient safety and privacy standards.
Automated External Defibrillator – Remediating Vulnerabilities in the Firmware Update Process in Response to FDA Hold Letter
Regulatory Submission Support Software Design & Development
Resolving an FDA hold for an AED manufacturer by fixing firmware update vulnerabilities—enabling regulatory approval, renewed sales, and improved postmarket cybersecurity.
Wearable ECG Device – Establishing Cybersecurity Policies and Procedures and Producing the eSTAR Document Set
Regulatory Submission Support Software & Firmware Testing Hardware Testing
Regulatory support for a wearable ECG device, including cybersecurity documentation, SDLC procedures, formal testing, and tailored eSTAR submission for FDA premarket guidance.
Mobile Cardiac Telemetry System – Cybersecurity Consulting Throughout the Product Development Lifecycle
Regulatory Submission Support Software & Firmware Testing Software Design & Development
Comprehensive cybersecurity consulting for mobile cardiac telemetry, throughout the full product development lifecycle.