Siddharth Jain is CEO and Chief Medical Device Regulatory Affair Advisor of Symbiorph Clinical Trialogy. The company started in year 2015 and based out in Ahmedabad.
He has more than 10 years of rich experience in Medical Device CE Certification, Clinical Evaluation, Post Market Clinical Follow-up (PMCF), Risk Management, Post Market Surveillance, Clinical Trial, Toxicological Analysis, and Usability Engineering.
He has supported many medical device manufacturing companies of India to accurately strategies their regulatory pathway and helps in earliest possible market entry in India, Europe and USA.
He is appointed as a mentor and advisor in various medical device focused incubation centers like Social Alpha, RICH, AIC-CCMB, AIC-GTU, Manipal-GOK Bioincubator, KIIT-TBI and many others.
Currently he is providing consulting service supporting for Voluntary Registration of Medical Device (Importer and Manufacturer), Import License, Manufacturing License as per Indian Medical Device Rule, 2017, Setting up the Manufacturing Facility, Quality Management System Certification as per ICMED and ISO 13485:2016, CE Certification as per the MDR 2017/745 and IVDR 2017/746 and USFDA 510k Approval.
Besides this he work with the medical device and IVD start from idea stage and help in Human Factory Engineering, Design Verification and Clinical Studies.