FDA Overview & Tips on Identifying Predicate Device – Oct 5th 2021 – Tuesday at 5 30 pm – 6 30 pm
SIIC IIT Kanpur in partnership with AIMED Invites you to a session on “FDA overview and Tips on Identifying Predicate Device” under Medtech Hour Series.
Medical device mixes include segments supervised by the FDA. Therefore, every blend product presents exceptional and testing administrative contemplations.
The process of navigating medical device compliances and regulations can be daunting for any medical devices startup or manufacturer. To simplify this experience, SIIC IIT Kanpur and AIMED have jointly organized a session on Food and Drug Administration (FDA) overview and tips on identifying predicate devices.
Join Startup Incubation and Innovation Centre, IIT Kanpur in partnership with Association of Indian Medical Device Industry (AIMED) in conversation with Mr Ajay Kumar Sankhla, Senior Consultant- Intertek USA & Mr Bhavesh Sheth, Senior consultant-Medical Intertek USA.
The speakers will provide an overview of the FDA process and dissect the identification of predicate devices, which is a crucial step in laying out a regulatory pathway.
Registration Link
Program Overview :
Session Highlights-
- Overview of FDA
- How to identify the suitable predicate device (in the context of the Indian regulatory framework)
- Consultancy charges for obtaining FDA (genuine vs non-genuine)
The Premise of the webinar series
IIT Kanpur is swiftly putting together an ecosystem in place to promote the next generation MEDICAL DEVICES entrepreneurs, disruptive technologies and thus contributing towards shaping the MEDTECH industry of tomorrow. Startup Incubation and Innovation Centre, IIT Kanpur is already supporting 25 startups in the MedTech domain encompassing IVDs, Medical Devices, Medical Equipment, telemedicine etc. The Institution is in the process of setting up:
(I) Mehta Family Foundation Centre for Engineering in Medicine– It is an academic program whereby engineers will be hired as faculty members to work on problems related to healthcare
(II) Super speciality hospital and Medical college – Here we plan to integrate programs in engineering and medicine. We have set up a School for Medical Research and Technology
This ecosystem shall deliver at a pace true to its DNA when the MedTech entrepreneurs are proficient in regulatory and Quality Certification pathways and adherence to the highest standards of quality is not plagued by ambiguity or lack of a level playing field.
Contact Coordinate :
Jatin Mishra
Manager (Biotech)
Startup Incubation and Innovation Centre
Indian Institute of Technology Kanpur
भारतीय प्रौद्योगिकी संस्थान कानपुर
Mob & Whatsapp : +91-9910195330
Address: SIDBI Building, Sixth Avenue