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DTSTART:20260825T050000Z
DTEND:20260825T080000Z
DTSTAMP:20260821T172830Z
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CREATED:20260818T101100Z
X-ALT-DESC;FMTTYPE=text/html:<h6 style="text-align: justify;"><strong> Regulatory compliance is more than a requirement. It is a critical part of building, validating, and bringing innovative medical technologies to market. </strong></h6>
<p style="text-align: justify;">For MedTech startups and bio-entrepreneurs developing <strong>Medical Devices, Software as a Medical Device (SaMD), or In-Vitro Diagnostic (IVD) products</strong>, understanding the right regulatory pathway early can help reduce uncertainty and accelerate the journey from innovation to market.</p>
<p style="text-align: justify;">The <strong>Regulatory Information and Facilitation Center (RIFC) at Venture Center</strong> is organizing <strong>R-Clinic for Startups</strong>, a unique opportunity for startups to gain personalized regulatory insights and interact one-on-one with regulatory experts.</p>
<p style="text-align: justify;">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.</p>
<p style="text-align: justify;"><img src="/storage/events/179/fb11b106-e793-4c08-a0e3-c2d95cf01dfd.png" alt="" width="1545" height="1999"></p>
<h6 style="text-align: justify;"><strong>What will you gain?</strong></h6>
<p style="text-align: justify;">Participating startups will get an opportunity to:</p>
<ul style="list-style-type: square;">
<li style="text-align: justify;">Discuss regulatory questions specific to their Medical Device, SaMD, or IVD product.</li>
<li style="text-align: justify;">Explore regulatory pathways for <strong>India, USA, and European markets</strong>.</li>
<li style="text-align: justify;">Understand applicable regulatory requirements and standards.</li>
<li style="text-align: justify;">Seek guidance on establishing and implementing a <strong>Quality Management System (QMS)</strong>.</li>
<li style="text-align: justify;">Discuss technical documentation and regulatory submission requirements.</li>
<li style="text-align: justify;">Gain practical insights from experienced regulatory professionals.</li>
</ul>
<h6 style="text-align: justify;"><strong>Who should attend?</strong></h6>
<p style="text-align: justify;">This mentoring opportunity is particularly relevant for <strong>MedTech startups, bio-entrepreneurs, founders, innovators, and teams</strong> 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.</p>
<h6 style="text-align: justify;"><strong>Topics for discussion</strong></h6>
<ul style="list-style-type: square;">
<li style="text-align: justify;">Planning Regulatory Pathway for <strong>India, USA, and EU</strong></li>
<li style="text-align: justify;">Health Insurance Portability and Accountability Act (<strong>HIPAA</strong>)</li>
<li style="text-align: justify;">Digital Personal Data Protection (<strong>DPDP) Act</strong> Advisory</li>
<li style="text-align: justify;"><strong>ISO 27001</strong> Information Security Management System</li>
<li style="text-align: justify;"><strong>ISO 13485</strong> Quality Management Standard</li>
<li style="text-align: justify;">Identification of Applicable Standards</li>
<li style="text-align: justify;"><strong>ISO 9001</strong> Quality Management Standard</li>
<li style="text-align: justify;">Risk Management</li>
<li style="text-align: justify;">Clinical Trial Advice</li>
</ul>
<h6 style="text-align: justify;"><strong>About the Mentors</strong></h6>
<p style="text-align: justify;"><strong>Chetna Dabi - Associate Manager, Regulatory Services, RIFC, Venture Center</strong></p>
<p style="text-align: justify;">Chetna works with the <strong>Regulatory Information and Facilitation Center (RIFC) at Venture Center</strong> 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 <strong>ISO 9001 and ISO 13485 QMS</strong>.</p>
<p style="text-align: justify;"><strong> <a href="http://linkedin.com/in/chetna-dharmavat-dabi-bb0598197" target="_blank" rel="noopener"> More about Chetna </a> </strong></p>
<p style="text-align: justify;"><strong>Akash Dhade - Associate Manager, Regulatory Services, RIFC, Venture Center</strong></p>
<p style="text-align: justify;">Akash works with the <strong>Regulatory Information and Facilitation Center (RIFC) at Venture Center</strong> and assists organizations in choosing regulatory pathways, creating technical documentation, and submitting documentation to notified bodies for the European market. He has <strong>10+ years of experience in QARA</strong>, with specialization in <strong>EU, US, and India</strong>, and is a Lead Auditor for <strong>ISO 13485 and ISO 9001</strong>.</p>
<p style="text-align: justify;"><strong> <a href="http://linkedin.com/in/connect-akash-dhade" target="_blank" rel="noopener"> More about Akash </a> </strong></p>
<h6 style="text-align: justify;"><strong>Mentoring Session Details</strong></h6>
<p style="text-align: justify;"><strong>Date:</strong> 25 August 2026</p>
<p style="text-align: justify;"><strong>Time:</strong> 10:30 AM - 01:30 PM</p>
<p style="text-align: justify;"><strong>Mode:</strong> Online via Google Meet</p>
<p style="text-align: justify;"><strong>Session Duration:</strong> 30 minutes per startup</p>
<p style="text-align: justify;"><strong>Seats:</strong> Limited</p>
<h6 style="text-align: justify;"><strong>How to Register</strong></h6>
<ul style="list-style-type: square;">
<li style="text-align: justify;">Complete the online registration form.</li>
<li style="text-align: justify;">Provide details about your startup/product and the regulatory questions you would like to discuss.</li>
<li style="text-align: justify;">Registration details will be screened by the organizers.</li>
<li style="text-align: justify;">Shortlisted participants will receive an email invitation along with the session joining link.</li>
</ul>
<p style="text-align: justify;"><strong> <span style="text-decoration: underline;"> Limited seats are available. Register now to secure your free mentoring slot. </span> </strong></p>
<p style="text-align: justify;"><strong> <a class="btn btn-outline-primary" href="https://forms.gle/X4dmVvnWcPcgwLAL6" target="_blank" rel="noopener"> Register Now </a> </strong></p>
<h6 style="text-align: justify;"><strong>Please Note:</strong></h6>
<ul style="list-style-type: square;">
<li style="text-align: justify;">The event is <strong>free of cost</strong>, but registration is mandatory.</li>
<li style="text-align: justify;">Each selected startup will receive a <strong>30-minute one-on-one mentoring session</strong>.</li>
<li style="text-align: justify;">Seats are limited and participants will be shortlisted based on the information provided during registration.</li>
<li style="text-align: justify;">Session joining details will be shared with shortlisted participants via email.</li>
</ul>
<h6 style="text-align: justify;"><strong>Take the opportunity to interact with regulatory experts and get focused guidance for your MedTech journey.</strong></h6>
<p style="text-align: justify;">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.</p>
<h6 style="text-align: justify;"><strong>For more details please contact:</strong></h6>
<p style="text-align: justify;">Aishwarya Varpe | <a href="mailto:aishwarya.varpe@venturecenter.co.in"> aishwarya.varpe@venturecenter.co.in </a> | +91-9156465137</p>
<p>&nbsp;</p>
DESCRIPTION: 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 Vent...
LAST-MODIFIED:20260821T172830Z
LOCATION:Online via Google Meet...
SEQUENCE:0
STATUS:CONFIRMED
SUMMARY: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.
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