Healthcare Startup Triumphs in FDA Compliance & Product Launch for Nerve Simulation Therapy Platform​

Client is an innovative healthcare technology startup dedicated to improving the lives of patients suffering from chronic Overactive Bladder (OAB) conditions.

Challenges

  • Reengineer data & app platform for scalability, reliability, security, & compliance.​
  • Support clinical trials for OAB & Urge Incontinence.​
  • Implement digital workflow from prescription to patient payment.​

Solutions

  • Detailed architecture reviews & redesign of system components.​
  • Implemented API gateway, serverless architecture & report generation API.​
  • Set up environments, data pipelines & telemetry.​
  • QA for app compatibility & secure boot for FDA compliance.​
  • Mature program management practices for visibility.​

Impact generated

  • Achieved FDA compliance in 6 weeks, ensuring timely launch.​
  • Flawless product launch with zero severity issues.
  • Enhanced company reputation & retained customers.​

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