top of page
Workshops
Workshop on Medical Device Regulations (20th & 21st Feb)
Venue: Board Room, Block D, R&I Park, IIT Delhi
Day 1, 20th Feb
TIME | TOPIC | SPEAKER(S) |
09:30-09:45 AM | Welcome Address | Prof. Dinesh Kalyanasundaram, IIT Delhi |
09:45-10:00 AM | Introduction and expectations of the Workshop | Dr. Suchita Markan, Sc.E MDMS, ICMR |
10:00-10:30 AM | High-Tea | |
10:30-11:30 AM | Session on Medical Devices/ IVDs - Regulatory Pathway for all classes | Dr. Ravi Kant Sharma, Deputy Drugs Controller, CDSCO |
11:30-12:30 PM | Lab to market translation for Orthotic and Rehab devices | Mr. Subhash N. N., Engineer 'C�, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum |
12:30-01:30 PM | Session on BIS Standards | Mr. P. V. Mathew, Joint Director, BIS |
01:30-2:30 PM | Lunch Break | |
02:30-03:00 PM | Session on Empowerment of Persons with Disabilities | Mr. Rajesh Aggarwal, IAS, Secretary, Dept. of Empowerment of Persons with Disabilities |
03:00-04:00 PM | Experiences of Conducting Clinical Investigation | Dr. Ashish Indani, Sr. Manager Clinical Affairs, Stryker |
04:00-5:00 PM | Session on Authentic 13485 Certificates | Mr. Anil Jauhri, Ex CEO, NABCB |
Day 2, 21st Feb
TIME | TOPIC | SPEAKER(S) |
10:00-11:00 AM | Session on overview of Medical Device Rules, 2017 | Mr. Omprakash Sadhwani, Former Joint Commissioner & Drugs Controller, FDA |
11:00-11:15 AM | High-Tea | |
11:15-12:00 PM | Clinical Studies and ethics involved | Dr. G. S. Bhuvaneshwar, Former Director, Bio-Medical Tech. Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum |
12:00-12:45 PM | Schedule 4 MDR - Product Compliance | Mr. M.G. Sathyendra, Consultant and Trainer, Qmart-Global |
12:45-01:30 PM | Schedule 5 MDR - Quality Management System including classification of technical areas | Mr. M.G. Sathyendra, Consultant and Trainer, Qmart-Global |
01:30-02:30 PM | Lunch Break | |
02:30-03:15 PM | Case Studies - Experiences on Clinical Trials for Orthopedic implants, etc. (Class C devices) | Dr. G. S. Bhuvaneshwar, Former Director, Bio-Medical Tech. Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum |
03:15-04:00 PM | Lab to market translation - Coronary Stent | Mr. Subhash N. N., Engineer 'C', Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum |
04:00-04:30 PM | Group Exercise & Case Studies | All experts |
04:30-05:00 PM | Open House Discussion and Closing Remarks | Prof. Dinesh Kalyanasundaram, IIT Delhi
Prof. Ravikrishnan Elangovan, IIT Delhi |
bottom of page