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DTSTART:20250526T053000Z
DTEND:20250526T063000Z
DTSTAMP:20260415T100732Z
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CREATED:20250516T115800Z
X-ALT-DESC;FMTTYPE=text/html:<h5 style="text-align: center;"><strong>Understanding FDA&rsquo;s Documentation Requirements for Software as Medical Device (SaMD)<span class="gmail_default">&nbsp;</span></strong></h5>
<h5 style="text-align: center;"><span class="gmail_default">Followed by one-on-one Mentoring session | 30 mins per slot |&nbsp;Selected&nbsp;5&nbsp;Slots<span style="color: #000000; font-size: large;">&nbsp;</span></span></h5>
<h5><strong>What to expect:</strong></h5>
<ul>
<li><span class="gmail_default"><span style="color: #000000; font-size: large;">Overview of SaMD and FDA Regulatory Pathways</span></span></li>
<li><span class="gmail_default"><span style="color: #000000; font-size: large;">Key Documentation Required for SaMD Submissions</span></span></li>
<li><span class="gmail_default"><span style="color: #000000; font-size: large;">Software Development Life Cycle (SDLC) and IEC 62304 Alignment</span></span></li>
<li><span class="gmail_default"><span style="color: #000000; font-size: large;">Best Practices for Submission and FDA Interactions<br></span></span></li>
</ul>
<h5><strong>Speaker:&nbsp; </strong><a href="https://www.linkedin.com/in/connect-akash-dhade/">Mr. Akash Dhade&nbsp;(Associate Manager &ndash; Regulatory Services)</a></h5>
<h5><strong>For more information contact</strong></h5>
<p>Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | <a href="tel:9156465137">9156465137</a></p>
<p><img style="display: block; margin-left: auto; margin-right: auto;" src="/storage/events/80/75ef7e42-06c9-4a50-972a-f633bafc0983.png" alt="" width="500" height="419"></p>
DESCRIPTION:Understanding FDA’s Documentation Requirements for Software as Medical Device (SaMD) 
Followed by one-on-one Mentoring session | 30 mins per slot | Selected 5 Slots 
What to expect:

Overview of SaMD and FDA Regulatory Pathways
Key Documentation Required for SaMD Submissions
Software Development Life Cycle (SDLC) and IEC 62304 Alignment
Best Practices for Submission and FDA Interactions

Speaker:  Mr. Akash Dhade (Associate Manager – Regula...
LAST-MODIFIED:20260415T100732Z
LOCATION:Zoom (Online)...
SEQUENCE:0
STATUS:CONFIRMED
SUMMARY: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.
TRANSP:OPAQUE
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