🏥 Specialized in Medical Device Technology

FDA-Ready Test Automation
for Medtech Companies

Built by a Test Automation Engineer with 5+ years at Tandem Diabetes Care.
Get reliable, compliant, and scalable automation using modern tools.

Trusted by medtech companies preparing for FDA submissions

5.7+
Years Experience
FDA
Compliant Testing
100%
Medtech Focused

Expert Test Automation with
Medical Device Industry Experience

I'm a Test Automation Engineer with 5 years and 7 months of experience at Tandem Diabetes Care, where I automated tests for patient-facing web applications used by thousands of medical professionals and patients.

At Tandem, I worked on FDA submissions and validation documentation, giving me deep understanding of what it takes to build test automation that meets regulatory requirements. I know the challenges medtech companies face when trying to balance speed with compliance.

Now, through Assert Edge Services, I help medtech companies build reliable, FDA-ready test automation using modern tools like Cypress, Selenium, and GitHub Actions. Whether you're preparing for your first submission or scaling your testing infrastructure, I can help you get there faster.

Technology Expertise

Cypress Selenium Appium JavaScript/TypeScript GitHub Actions Postman/API Testing CI/CD Pipelines

Proven Experience in Medical Device Software

Test Automation Engineer

Tandem Diabetes Care, Inc.

2020 - 2025 • 5.7 years

Key Achievements & Responsibilities:

  • Automated testing for patient-facing web applications used by medical professionals and patients with diabetes
  • Contributed to FDA submission documentation including test protocols, traceability matrices, and validation reports
  • Built test automation frameworks using Cypress and Selenium for web applications
  • Implemented CI/CD pipelines with GitHub Actions for automated test execution
  • Developed mobile test automation using Appium for iOS and Android applications
  • Created API test suites using Postman and JavaScript for backend validation
  • Collaborated with cross-functional teams including product, engineering, and regulatory to ensure software quality and compliance

FDA & Compliance Experience:

  • Worked in FDA-regulated environment for 5.7 years
  • Created test documentation for regulatory submissions
  • Built test frameworks with audit trail and traceability requirements
  • Collaborated with regulatory team on validation protocols

Comprehensive Test Automation Solutions

From initial setup to ongoing maintenance, I provide end-to-end test automation services tailored for medtech companies.

Not sure which package is right for you? Schedule a free consultation to discuss your needs.

Why Medtech Companies Choose Assert Edge Services

🏥

Medtech Specialized

Deep understanding of HIPAA, FDA regulations, and medical device software requirements from years at Tandem Diabetes Care.

📋

FDA Documentation

Experience creating test documentation, traceability matrices, and validation protocols that meet FDA submission requirements.

Modern Tech Stack

Using the latest tools (Cypress, GitHub Actions) that medtech companies actually use, not outdated legacy frameworks.

🎯

Industry Focused

Understand the unique challenges of medtech: limited resources, tight timelines, and the need to move fast while staying compliant.

🔄

End-to-End Support

From initial setup to CI/CD integration to ongoing maintenance, I provide comprehensive support at every stage.

💪

Proven Experience

5.7 years at a leading medical device company, working on software used by thousands of patients and medical professionals.

Ready to Build FDA-Ready Test Automation?

Schedule a free 30-minute consultation to discuss your testing needs and how I can help.

Schedule Free Consultation

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