🏥 Specialized in Healthcare Technology

FDA-Ready Test Automation
for Healthcare Startups

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

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Trusted by healthcare startups preparing for FDA submissions

5.7+
Years Experience
FDA
Compliant Testing
100%
Healthcare Focused
About Assert Edge Services

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 healthcare 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 healthcare startups face when trying to balance speed with compliance.

Now, through Assert Edge Services, I help healthcare startups 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
Professional Background

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 healthcare 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

Regulatory & Compliance Knowledge:

  • 21 CFR Part 11 (FDA Electronic Records)
  • IEC 62304 (Medical Device Software Lifecycle)
  • Risk-based testing approaches (ISO 14971)
  • Test documentation for regulatory submissions
  • Design controls and traceability requirements
Services

Comprehensive Test Automation Solutions

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

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

Why Healthcare Startups Choose Assert Edge Services

🏥

Healthcare 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 healthcare startups actually use, not outdated legacy frameworks.

🎯

Startup Focused

Understand the unique challenges of startups: 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 healthcare professionals.

Ready to Build FDA-Ready Test Automation?

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

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Get In Touch

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