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DTSTART:20250930T103000Z
DTEND:20250930T113000Z
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X-ALT-DESC;FMTTYPE=text/html:<h3 style="text-align: center;"><span style="font-size: 24pt;">&nbsp; Navigating FDA Premarket Notifications (510k) and Preclinical Testing</span><br><span style="font-size: 18pt;">A Practical Guide for Indian MedTech Start-ups </span></h3>
<h6><strong>What to expect</strong></h6>
<p>Gain insights into the specific requirements and best practices for US FDA medical device submissions.&nbsp;</p>
<ul>
<li>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.</li>
<li>Preclinical testing strategies, with a focus on performance studies, biocompatibility assessments under ISO 10993, and verification and validation strategies.</li>
<li>Practical examples on structuring test protocols, justifying sample sizes, documenting verification and validation results, and tips for making a submission &ldquo;easy to review.&rdquo;&nbsp;</li>
</ul>
<h6><strong>Speaker: </strong><a href="https://www.linkedin.com/in/tanmay-jain8491/">Tanmay Jain</a></h6>
<p>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..</p>
<p><strong>Selected 4 startups get a chance to have one-on-one mentoring with the expert. [Details of the mentoring slots will be shared separately with the selected startups]</strong></p>
<h6><strong>For Queries</strong></h6>
<p>Aishwarya Varpe | <a href="mailto:aishwarya.varpe@venturecenter.co.in">aishwarya.varpe@venturecenter.co.in</a> | <a href="tel:9156465137">9156465137</a></p>
<p><a class="btn btn-outline-primary" href="https://forms.gle/EhTsdPavFjhUPTtW6">Register</a></p>
<hr>
<p>&nbsp;</p>
<h6><strong>Post Event</strong></h6>
<p><a href="/storage/events/102/4c9555de-cee6-453a-babd-c6660ed20cd7.pdf">Access Event Report summarizing the session outline, participant details, and feedback</a></p>
<p><img style="display: block; margin-left: auto; margin-right: auto;" src="/storage/events/102/c3b69f93-e031-4bbb-a499-b0546f1dfa82.png" alt="" width="500" height="500"></p>
<p>&nbsp;</p>
DESCRIPTION:  Navigating FDA Premarket Notifications (510k) and Preclinical TestingA Practical Guide for Indian MedTech Start-ups 
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 test...
LAST-MODIFIED:20260415T054020Z
LOCATION:Venture Center...
SEQUENCE:0
STATUS:CONFIRMED
SUMMARY: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.
TRANSP:OPAQUE
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