Preethi Thiruna

Medical Devices - DHF Remediation

Role
Lead Engineer at HCLTech
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers

About Preethi Thiruna

I am a Regulatory Affairs Professional specializing in U.S. FDA submissions for medical devices, with expertise in preparing and managing 510(k) submissions. My experience extends to compiling regulatory documentation for software-based devices, including cybersecurity management, risk analysis, and validation deliverables, ensuring alignment with FDA expectations. I am passionate about helping organizations navigate complex regulatory requirements and achieve timely market clearance, while maintaining the highest standards of quality, safety, and compliance.

Experience

  1. Lead Engineer

    HCLTech

    Oct 2025 — Present · Madurai, IN

Education

  • The Oxford College of engineering

    Bachelor of Engineering - BE, Biotechnology

  • Narayana PU college

    PCMB

    2016 — 2018

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Preethi Thiruna — Lead Engineer at HCLTech in Bengaluru, KA, IN | Unifers