The session will be covering:
- Regulations an Overview
- Upcoming new regulations- Worldwide
- MDR approval
- Translations
- Regulatory Challenges and Solutions
Speaker: Mrs Gayathri Ganesan, Principal Regulatory Affairs Consultant, OMC Medical
Gayathri Ganesan, qualified with Masters in Biomedical Engineering and has experience working with leading medical device manufacturers brings in her experience with product management strategies and resolving complexities with major markets in the medical device industry which includes GCC, EU and ROW. She has worked with company acquisitions dealing with challenging regulatory situation and license transfers. Her experience also includes working with breakthrough technology approvals with EU and FDA.
Location: ABHI & DIT Stand: Hall 2, D30