Technical Director, Medical Devices Certification
DEKRA Certification B.V.
Harshit S. Thakkar (HT) is Technical Director, Medical Devices at DEKRA Certification Inc./B.V., where he leads a team of project managers, auditors, and technical file reviewers and oversees assessments and audits for market access under EU MDR, ISO 13485, ISO 9001, and MDSAP. A qualified notified-body lead auditor and technical file reviewer, he has directed 100+ conformity-assessment projects and evaluated 50+ dossiers across active and non-active technologies. His technical focus spans human factors/usability, ISO 14971 risk management, packaging and shelf life, design verification/validation, and process validation—capabilities aligned with the demands of drug–device combination products.
HT has trained and qualified auditors and reviewers, mentored teams, represented DEKRA in industry forums. He has served as Knowledge Manager for usability engineering, chaired the TIC Council’s Medical Device Working Group (India), and delivered sessions to regulators and industry. He holds an MS in Medical Device & Diagnostic Engineering from the University of Southern California.
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Workshop: Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions
Wednesday, November 12, 2025
12:30 PM - 3:00 PM East Coast USA Time