Contact us
Case Studies

Security & Compliance Testing for FDA-Ready Patient Monitoring Device

The product is an all-in-one remote patient monitor that combines ECG, stethoscope, pulse oximetry, temperature, and blood pressure tracking in a single device.It connects with a companion app and cloud service to enable real-time tele-health monitoring.Designed for wellness and cardiac care,
Challenges Faced by the Client

The key challenge was achieving FDA certification without source code access, requiring a black-box testing approach to validate security and compliance with FDA, HIPAA, and GDPR standards.

FDA Certification Readiness

FDA Certification Readiness

The primary requirement was to secure FDA certification clearance for a connected healthcare platform. FDA guidelines mandate strong evidence of secure coding practices, typically validated through Static Application Security Testing (SAST). This created a challenge, as the assessment needed to ensure compliance not only with FDA standards but also with HIPAA and GDPR regulations governing sensitive health data.

Black-Box Testing Approach

Black-Box Testing Approach

Due to internal compliance and intellectual property restrictions, the source code for the mobile application and firmware was not shared, limiting the ability to conduct SAST — a key FDA requirement. To address this, a black-box testing approach was adopted, including firmware binary analysis, mobile application DAST, and protocol security testing to identify vulnerabilities and support compliance efforts.

Testvox Approach

Testvox adopted a structured, FDA-aligned security assessment combining black-box testing, binary analysis, and penetration testing of both the mobile application and firmware to uncover vulnerabilities and ensure compliance readiness.

Scope of Work

Scope of Work

The engagement covered a penetration test of the Android mobile application and a firmware security assessment. Both components were analyzed to uncover weaknesses that could compromise sensitive patient data, device safety, or regulatory compliance.

Methodology

Methodology

The assessment followed OWASP Mobile Top 10, OWASP Firmware Security Standards, and CWE/SANS Top 25. A combination of static and dynamic analysis with manual penetration testing ensured both breadth and depth of coverage against real-world threats.

Tools

Tools

Industry-standard and proprietary tools were used, including Burp Suite, MobSF, AppScan, Ghidra, Binwalk, Wireshark, Nmap, and SSLScan. These were complemented by Testvox’s internal frameworks to enhance detection accuracy and validate findings across multiple testing layers

Testing Focus Areas

Testing Focus Areas

The focus areas included authentication and session management, data storage and PHI handling, and API communication with cryptography enforcement. In addition, the firmware boot process, memory management, and communication stack were mapped against FDA cybersecurity guidelines for medical device safety.

Collaboration with Client Teams

Collaboration with Client Teams

Throughout the engagement, Testvox worked closely with the client’s QA and engineering teams to ensure smooth execution despite the absence of source code access. Clear communication, structured evidence sharing, and remediation guidance helped bridge internal compliance restrictions while still aligning with FDA certification expectations.

Compliance Alignment

Compliance Alignment

All assessments were mapped against FDA cybersecurity guidance, as well as HIPAA and GDPR requirements. This ensured that identified vulnerabilities were not only technical risks but also framed in terms of regulatory impact, patient safety, and certification readiness, giving the client a clear roadmap for remediation and future audits.

Outcomes & Business Impact

The assessment strengthened security, supported FDA/HIPAA/GDPR compliance, reduced risks, and enhanced trust in the healthcare platform.

Risk Reduction

No critical vulnerabilities were identified, but multiple high and medium risks were uncovered that could have led to data compromise, device tampering, or regulatory gaps.

Compliance Alignment

Findings were mapped against FDA cybersecurity guidance, HIPAA, and GDPR, providing a clear and prioritized remediation roadmap for certification readiness.

Enhanced Security Posture

Testvox recommended measures such as secure APK signing, encrypted data storage, secure firmware boot, stronger BLE pairing, and removal of debug artefacts, significantly strengthening overall product security.

Trust & Safety

By addressing these vulnerabilities, the solution now ensures better protection of sensitive health data, reduced operational risks, and improved trust with both end-users and regulators.

I had the privilege of performing comprehensive security testing for both the firmware and Android application of a healthcare mobile app with Testvox, where I was able to identify critical to high-risk vulnerabilities such as insecure firmware updates, hardcoded credentials, insecure data storage, insufficient authentication controls, and exposure of sensitive healthcare information.
Sahib Oberoi Security Engineer at Testvox | OSCP, CISM, CEH
UPDATES

Chime in on some Testing updates here

Ecommerce Order Management System – Commerce Layer Testing Guidelines

Commerce Layer testing guidelines for e-commerce order management systems. 
READ MORE

E-commerce Search Engine – Typesense Testing Guidelines

Test and optimize your eCommerce search with Typesense
READ MORE

E-commerce  Product Listing &  Product Detailing Page Testing Guide

Learn how to test Product Listing Pages (PLP) and Product Detail Pages (PDP) in e-commerce. Discover common bugs, top test cases
READ MORE

ERP-Ecommerce integration Testing

How to ensure seamless ERP–ecommerce integration with robust testing. Learn the key focus areas, top test cases, and common bugs 
READ MORE

E-commerce Cart and Checkout Functionality Testing: Common Bugs, Test Cases, and Best Practices

Common bugs, test cases, and best practices for e-commerce cart and checkout testing
READ MORE

Meet the Tester- Ms. Supriya Srivastav

Supriya Srivastav, QA Analyst at Testvox, as she shares insights on her daily role, favorite tools, collaboration with teams, career highlights, and passion for delivering quality software
READ MORE

E-commerce Testing Service Company in India

Looking for the best e-commerce testing company in India? Testvox is a leading provider, offering complete end-to-end e-commerce testing services.
READ MORE
Meet Our Software Test QA Lead : Ms. Soumya

Meet Our Software Test QA Lead : Ms. Soumya

Meet Testvox’s Software Testing Lead, Soumya, and explore her inspiring journey, passion for quality assurance, and the vibrant team culture that drives excellence at Testvox.
READ MORE