Regulatory compliance is more than a requirement. It is a critical part of building, validating, and bringing innovative medical technologies to market.
For MedTech startups and bio-entrepreneurs developing Medical Devices, Software as a Medical Device (SaMD), or In-Vitro Diagnostic (IVD) products, understanding the right regulatory pathway early can help reduce uncertainty and accelerate the journey from innovation to market.
The Regulatory Information and Facilitation Center (RIFC) at Venture Center is organizing R-Clinic for Startups, a unique opportunity for startups to gain personalized regulatory insights and interact one-on-one with regulatory experts.
Through focused mentoring sessions, participating startups can discuss their specific regulatory questions, understand applicable standards and regulatory pathways, and seek guidance on quality management and regulatory documentation.
What will you gain?
Participating startups will get an opportunity to:
- Discuss regulatory questions specific to their Medical Device, SaMD, or IVD product.
- Explore regulatory pathways for India, USA, and European markets.
- Understand applicable regulatory requirements and standards.
- Seek guidance on establishing and implementing a Quality Management System (QMS).
- Discuss technical documentation and regulatory submission requirements.
- Gain practical insights from experienced regulatory professionals.
Who should attend?
This mentoring opportunity is particularly relevant for MedTech startups, bio-entrepreneurs, founders, innovators, and teams developing Medical Devices, Software as a Medical Device (SaMD), or In-Vitro Diagnostic (IVD) products who are looking for guidance on regulatory strategy, compliance, quality systems, standards, or market access.
Topics for discussion
- Planning Regulatory Pathway for India, USA, and EU
- Health Insurance Portability and Accountability Act (HIPAA)
- Digital Personal Data Protection (DPDP) Act Advisory
- ISO 27001 Information Security Management System
- ISO 13485 Quality Management Standard
- Identification of Applicable Standards
- ISO 9001 Quality Management Standard
- Risk Management
- Clinical Trial Advice
About the Mentors
Chetna Dabi - Associate Manager, Regulatory Services, RIFC, Venture Center
Chetna works with the Regulatory Information and Facilitation Center (RIFC) at Venture Center and assists medical device startups in planning regulatory pathways, interpreting standards, and establishing and implementing Quality Management Systems for medical devices. She is a certified lead auditor for ISO 9001 and ISO 13485 QMS.
Akash Dhade - Associate Manager, Regulatory Services, RIFC, Venture Center
Akash works with the Regulatory Information and Facilitation Center (RIFC) at Venture Center and assists organizations in choosing regulatory pathways, creating technical documentation, and submitting documentation to notified bodies for the European market. He has 10+ years of experience in QARA, with specialization in EU, US, and India, and is a Lead Auditor for ISO 13485 and ISO 9001.
Mentoring Session Details
Date: 25 August 2026
Time: 10:30 AM - 01:30 PM
Mode: Online via Google Meet
Session Duration: 30 minutes per startup
Seats: Limited
How to Register
- Complete the online registration form.
- Provide details about your startup/product and the regulatory questions you would like to discuss.
- Registration details will be screened by the organizers.
- Shortlisted participants will receive an email invitation along with the session joining link.
Limited seats are available. Register now to secure your free mentoring slot.
Please Note:
- The event is free of cost, but registration is mandatory.
- Each selected startup will receive a 30-minute one-on-one mentoring session.
- Seats are limited and participants will be shortlisted based on the information provided during registration.
- Session joining details will be shared with shortlisted participants via email.
Take the opportunity to interact with regulatory experts and get focused guidance for your MedTech journey.
Whether you are working on a Medical Device, SaMD, or IVD, the R-Clinic is designed to help you better understand the regulatory landscape and identify the next steps toward compliance and market readiness.
For more details please contact:
Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | +91-9156465137