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
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
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
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
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
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
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 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
Comprehensive cybersecurity consulting for mobile cardiac telemetry, throughout the full product development lifecycle.