Navigating FDA Premarket Notifications (510k) and Preclinical Testing by Tanmay Jain скачать в хорошем качестве

Navigating FDA Premarket Notifications (510k) and Preclinical Testing by Tanmay Jain

RIFC @Venture Center is happy to announce Awareness Talk Navigating FDA Premarket Notifications (510k) and Preclinical Testing: A Practical Guide for Indian MedTech Start-ups 30 September 2025 | 4:00 PM - 5:00 PM | Hybrid Mode Event Details: 💡 What to expect: Gain insights into the specific requirements and best practices for US FDA medical device submissions. FDA regulatory pathways and resources for med-tech startups, including how to determine substantial equivalence, select a predicate for the 510(k) Premarket Notification process, navigate timelines, and request reviewer feedback. Preclinical testing strategies, with a focus on performance studies, biocompatibility assessments under ISO 10993, and verification and validation strategies. Practical examples on structuring test protocols, justifying sample sizes, documenting verification and validation results, and tips for making a submission “easy to review.” 🗓️ Date: 30 September 2025 🕓 Time: 04:00 PM – 05:00 PM 📍 Mode: Hybrid (In-Person at Venture Center & Online on Zoom) 👤 Speaker: Tanmay Jain A polymer scientist with 6+ years at the U.S. FDA (CDRH) as a lead reviewer, specializing in polymer-based medical devices. His expertise spans device performance, biocompatibility, and regulatory standards, covering implants, surgical tools, and 3D-printed technologies. He co-founded ProfProtects, an award-winning startup developing opioid-detecting polymer mats, now being licensed globally. He currently advises med-tech startups on regulatory strategy, materials evaluation, preclinical testing, and product development.