Dear all,

The IIT Madras HTIC Medtech Incubator is excited to initiate the “Regulatory” series. The aim of this series is to bring subject matter experts from different domains to share insights on the upcoming trends, technologies and bottlenecks. Monthly dose of Training Programs to further empower the entrepreneurs/ start-ups to acquire and develop on their existing knowledge on different aspects of entrepreneurship. The session “Regulatory” will be hosted once in a quarter.

Speaker: Siddharth Jain, CEO and Chief Medical Device Regulatory Affair Advisor, Symbiorph Clinical Trialogy

Topic for Session: Regulatory Requirements for AI/ML based Software as a Medical Device (SaMD)

Date: 20 Dec 2022

Time: 10.30 am to 12.30pm

To register the Session: Registration Link

Siddharth Jain-CEO & Chief Medical Device Regulatory Affair Advisor, Symbiorph Clinical Trialogy. LinkedIn

Siddharth Jain is CEO and Chief Medical Device Regulatory Affair Advisor of Symbiorph Clinical Trialogy. The company started in 2015 and is based out in Ahmedabad. He has more than 9 years of rich experience in strategizing the Medical Device Market Accesses for medical device companies and provide end-to-end solution for CE Certification, Clinical Evaluation, Post Market Clinical Follow-up (PMCF), Risk Management, Post Market Surveillance, Clinical Validation, Toxicological Analysis, and Usability Engineering. He has supported many start-ups, small and mid-medical device manufacturing companies of India to accurately strategies their regulatory pathway and helps in the earliest possible market entry in India, Europe and USA. Currently he is supporting the Medtech start-ups in Indian Medical Device Rule, 2017 and CE Certification as per the MDR 2017/745 and IVDR 2017/746 for the Indian and European Countries respectively.