Knowledge Tuesday with Siddharth Jain, CEO & Chief Medical Device Regulatory Affair Advisor, Symbiorph Clinical Trialogy on June 30, 2020 @ 5pm to 6pm.
#Knowledge Tuesday
The IIT Madras HTIC Medtech Incubator is excited to initiate the “Knowledge Tuesday” 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 . Weekly dose of knowledge to further empower the entrepreneurs/ start-ups to acquire and develop on their existing knowledge on different aspects of entrepreneurship. The Knowledge Tuesday will be hosted every Tuesday.
Speaker: Siddharth Jain, CEO and Chief Medical Device Regulatory Affair Advisor, Symbiorph Clinical Trialogy (LinkedIn)
Topic for the week: Medical Device & IVD CE Certification Requirements
Date: 30 June 2020
Time: 5 pm to 6 pm
Registration link: https://forms.gle/vs518LZxPpP3oZFB9
Link to join the session: https://meet.google.com/gtc-hfqb-ojq
Key Takeaways
- What is CE Certification?
- What is European Union accredited Notified Body?
- Key changes in MDR 2017/745
- How you can classify your Medical Device?
- Key changes in IVDR 2017/746
- Timeline to achieve the certification
Siddharth Jain-CEO & Chief Medical Device Regulatory Affair Advisor, Symbiorph Clinical Trialogy
Siddharth Jain is CEO and Chief Medical Device Regulatory Affair Advisor of Symbiorph Clinical Trialogy. The company started in 2015 and 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.
