Events
One-on-One Mentoring: Regulatory Requirements for MedTech Startups
Venture Center’s Regulatory Information and Facilitation Center (RIFC) is offering free, one-on-one mentoring for startups developing Medical Devices, SaMDs, and IVDs. Discuss your questions with Chetna Dabi, Associate Manager, Regulatory Services, on regulatory pathways, applicable standards, quality management, data protection, risk management, and clinical trials. Read more
Navigating Food Safety, Regulation & Market Challenges
Join “Navigating Food Safety, Regulation & Market Challenges” with Ms. Vaidehi Kalzunkar, Deputy Director (Technical), FSSAI Western Regional Office. The session will explore food industry trends, regulatory compliance, food testing, emerging retail models, and responsible food entrepreneurship. Read more
R-Clinic for Startups developing Medical Devices, SaMD, or IVDs
R-Clinic for Startups is a free one-on-one regulatory mentoring opportunity organized by the Regulatory Information and Facilitation Center (RIFC) at Venture Center for startups and bio-entrepreneurs developing Medical Devices, Software as a Medical Device (SaMD), or In-Vitro Diagnostics (IVDs). Participants can interact with experienced regulatory professionals to discuss regulatory pathways, applicable standards, quality management systems, risk management, clinical trial advice, and regulatory requirements for India, the USA, and the EU. The mentoring sessions are designed to provide focused, practical guidance to help startups better understand regulatory requirements and plan their path toward compliance and market readiness. Read more
Awareness Talk on India's DPDP Act in Healthcare
Patient data is among the most sensitive information an organization handles. Is your organization prepared for India's Digital Personal Data Protection (DPDP) Act? Join us for an insightful awareness session and learn the key requirements of the DPDP Act and what they mean for healthcare organizations. Read more
Introduction & Internal Auditors Training Course for ISO 13485:2016
This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485 and ISO 19011. Read more
Regulatory Strategies and Best Practices for Agri-Biologicals
The session will help agri-input startups and innovators navigate India’s regulatory landscape for fertilizers, pesticides, and agrochemicals, featuring insights from Dr. Sawan Kumar (Sea6 Energy) and Dr. Renuka Diwan-Karandikar (BioPrime Agrisolutions). Read more
Navigating FDA Premarket Notifications (510k) and Preclinical Testing:Practical Guide for Indian MedTech Start-ups
Join us for a practical guide on navigating the FDA 510(k) submission process and preclinical testing, tailored for Indian MedTech start-ups. Learn key regulatory pathways, predicate selection, preclinical testing strategies, and tips to make your submission reviewer-friendly with real-world examples. Read more
Understanding FDA’s Documentation Requirements for Software as Medical Device (SaMD)
Join us for a session on understanding FDA’s documentation requirements for Software as a Medical Device (SaMD), covering regulatory pathways, key submission documents, and SDLC alignment with IEC 62304. Followed by exclusive one-on-one mentoring slots for personalized guidance. Read more
MedTech:Doing Business in the USA
Talk on “MedTech: Doing Business in the USA” by Aditya Ingalhalikar, Ph.D. (Founder & CEO of BioAlign Inc.,USA) Read more
Awareness Talk on FDA’s QMSR Final Rule
Awareness Talk on the FDA’s Quality Management System Regulation (QMSR) Final Rule for medical device manufacturers. Read more