Beyond Scrubs (Reg + Non Clinical Collective)
About Hello there — I'm Dr. Irene Thomas

Your trusted expert and guide
for regulatory & clinical requirements

My work focuses on turning complex regulatory and clinical requirements into clear strategies and high-quality reports, delivered within timelines. Whether it's a new device, a legacy product or a global portfolio, I support companies in reducing uncertainty and strengthening their compliance foundation.

5+ Years in MedTech Regulatory Affairs
EU MDR Clinical Evaluation Specialist
MDSAP Certified Auditor
Board Certified Dentist
Dr. Irene Thomas at her desk Clinical Evaluation Regulatory Guide

Beyond Scrubs: From Clinical Practice to Compliance

A dentist turned regulatory professional with 6+ years in MedTech — I bridge the gap between innovative engineering and complex regulatory pathways: crafting compliant, high-quality documentation to get your device approved faster.

Experience

What I support teams with

Over the past years, I've supported manufacturers, startups and MedTech teams with:

My approach is simple: clarity, accuracy and proactive execution — no surprises, no last-minute reworks, no compliance gaps. First time right.
Support with EU MDR clinical documentation, FDA submissions, CDSCO registration & LAR, global market entry, or smart regulatory strategy — feel free to reach out.
Message me anytime. Happy to connect and collaborate with MedTech teams towards safe, effective and compliant devices.
EU MDR FDA CDSCO ISO 13485 ISO 14971 ISO 14155 MDSAP RAPS Professional NIDA ICH-GCP ISO 45001 : 2018

Credentials and Expertise

  • 6+ Years Medical Device Regulatory Affairs
  • EU MDR Clinical Evaluation Specialist
  • MDSAP Certified Auditor
  • ISO 13485 Certified Internal Auditor
  • ISO 45001:2018 Internal Auditor
  • Regulatory Strategy · CER · PMS · PMCF
  • NIDA ICH-GCP Certified
  • Project Management
  • Senior Mentor for RA, Clinical Evaluation & PMS
  • Certified in Medical Writing