Vivek Sagayaraj
AI/ML-MDSW, Digital pathology, RA/QA, CQI-IRCA-LA. 21 CFR, EU AI Act , EU MDR/IVDR, 510(k),CE submission for Class II ,III MDs and Class C IVDs. ISO 13485/14971 & IEC 62304/ 62366 standards.
- Role
- Regulatory Affairs Manager at HCLTech
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Vivek Sagayaraj
Doctorate with 9 plus years of industrial experience in Medical device/IVD/AI-ML based…
Experience
Regulatory Affairs Manager
Feb 2023 — Present · IN
AI/ML based medical device software, digital pathology, IVDR, SDLC,Risk management, Usability, Internal auditor
Education
University of Madras
Doctor of Philosophy - PhD
2012 — 2017
Loyola College
B.Sc.
2006 — 2009
Dr ALM PG Institute For Basic Medical Sciences
M.Sc.
2009 — 2011
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